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Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities in support of Stability. Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Stability studies and Stability area/equipment; creating, reviewing, executing activates for, and approving documentation; detailing requirements and requesting LIMS (Laboratory Information Management System) builds and master data changes; stability regulatory submissions document creation and review; initiate and project manage change controls; support audits as Stability subject matter expert; analyzing, interpreting, and trending results/data; participating in investigations of events/out of specification results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents Quality Control on cross functional teams; and leads projects and/or teams providing guidance/training/coaching to junior colleagues.
The individual should be able to demonstrate the following:
acting safely, knows and follows all Environmental Health and Safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely
recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards
excellent effective written and verbal communication and interpersonal skills; established relationships within business lines
ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues
applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals
solving highly complex problems and situation dependent problems using convoluted information
method 1, yellow belt trained and can apply tools to solve issues (including technical issues)
ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior
good judgment and correct decision making based on Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network
represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements
proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule
delivery on high business impact projects/activities/changes
able to create, review, and approve compliant equipment qualification/computer validation records; assist with protocol non-conformance evaluations
able to identify and seek out external resources to build or enhance understanding of stability concepts and compliance; supports training of staff; mentoring and coaching junior colleagues
capability of detailing requirements for LIMS builds and LIMS Master Data changes
Individual should have knowledge of US, EU, and ROW cGxP; ICH guidelines; analytical chemistry and/or Microbiology techniques; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
Responsible for knowing,understanding and acting in accordance with Pfizer’s values
Performs tasks associated with maintaining cGMP compliant Stability and Stability area/equipment.
Completes activities to implement Stability protocols and studies for new products and annual stability for commercial products
Forecasting for QC Labs expected Stability pulls and performs Stability pulls
Evaluates change control for Stability impact
Conducts stability impact assessments for investigations
Completes actions for end of studies and sample disposal
Stability Annual Product Record Review
Metric tracking and reporting
Providing investigation support and troubleshooting stability issues
Maintenance and continuous improvement of Stability procedures and processes
Stability regulatory submissions document creation and review
Responsible for requesting detailed LIMS builds and LIMS Master Data changes.
Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, equipment validation protocols/reports, equipment records, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
May analyze and interpret results, make decisions regarding their completeness and compliance; may perform data trending
Responsible for reporting issues to management and participating in issue resolution
Initiate and project manage change controls
Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
May initiate, manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
Trains junior colleagues and may develop training plans and/or oversee training activities
Responsible for assessing existing QC situations and suggesting continuous improvements to increase compliance and innovation.
Must-Have
High School Diploma (or Equivalent) and 10 years of relevant experience , OR Associate’s Degree (Preferred in Science) with 8 years of experience, OR Bachelor’s Degree (Preferred in Science) with at least 5 years of experience, OR Master’s Degree (Preferred in Science) with at least 3 years of experience, OR PhD and 2 years or less
Experienced and proficient with laboratory practices, good knowledge of Stability, Good Manufacturing Practices (cGMP), and compliance requirements for Quality Control Laboratories ( preferred in Pharma industry)
Nice-to-Have
Experience defending work in regulatory audits.
Experience leading continuous improvement projects and knowledge of lean manufacturing, six sigma methodologies and statistics.
Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
Intellectual capability to perform complex mathematical problems and perform complex data analysis.
Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
Last day to apply: October 10th, 2023
Employee Referral Bonus eligible
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Official account of Jobstore.
Job Description:
Introduction
At GAF Commercial we cover more than buildings. We cover each other. No matter what role, tenure, or department, under this roof you are helping to build the market leader in commercial roofing. Under this roof, we are assembling a winning team that puts the customer at the center of every decision and doesn't back down from hard work. Under this roof, we support one another in delivering operational excellence daily, while working to make a positive impact for our planet and our communities. Becoming the market leader only happens when everyone feels they have the opportunity, and the support, to thrive. We are GAF. And under this roof, we protect what matters most.
About GAF – Valdosta, GA
Valdosta is a diverse, lively city in southern Georgia. Just miles from Florida, Valdosta is also only a few hours from Disney World or the beach, and is conveniently located between Jacksonville and Atlanta.
Team or Function Overview
Our world class company is growing our commercial business, and GAF is opening its newest state of the art TPO Commercial Roofing plant in Valdosta. Being part of a startup team is a fun and rewarding opportunity, so come to GAF and enjoy Valdosta’s lifestyle. There's never been a better time to join our company!
Summary
The Quality Control Technician III is responsible for providing impeccable support to the Production Teams at the Valdosta Plant. The ideal candidate thrives in environments where safety, quality, service and cost are the highest priorities. The Quality Control Technician will perform various quality systems and testing activities for manufacturing operation, including raw material, quality audits, plant trials, quality lab maintenance and organization.
Essential Duties
Specific responsibilities include, but are not limited to:
● Review real time product quality on a consistent basis
● Participating or lead audits of the quality systems with external auditors
● Assists and supports the Process Engineer and Technical Services Manager with projects as needed
● Generate timely, consistent reports to ensure quality specifications are met
● Perform raw material and physical property tests
● Communicate effectively with production operators and leaders
● Audit lab and manufacturing processes
● Evaluates and confirms whether to reject or pass finished roofing products by testing samples
● Provide updates to the plant MSDS database as needed
● Order routine lab supplies through approved processes and approvals
● Maintain lab calibrations and documentation
● Assure all activities are performed safely
● Participate in new material trials in coordination with R&D
● Verifies and inspects incoming raw materials
● Works safely to prevent on-the-job injuries
● Maintains raw material and finished product specs, controlled documents, calendar, and email using the google suite of products
● Makes necessary adjustments by notifying operator and/or manager and retesting product
● Tests multiple samples by using averages
● Checks data readings to specification by performing unit conversions
● Maintains housekeeping with consistent lab and facility maintenance
● Additional projects and tasks may be assigned as business needs require
Physical Demands
● Ability to read and concentrate via computer data entry typing and proofreading
● Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
● Frequent sitting, walking and standing; occasional climbing, stooping, kneeling, crouching, crawling and balancing
● Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone
● Required to sit, stand, walk and use hands to grasp, handle or feel objects, tools and product samples
● Specific vision abilities required by this job include close vision, peripheral vision, depth perception and the ability to adjust focus
● Must continuously have the ability to differentiate colors precisely
● Required to reach with hands and arms and stoop, kneel or crouch
● Ability to perform detailed testing processes in various process conditions
● Frequent use of eye, hand and finger coordination enabling the use of testing equipment and machinery
● Regularly lift and/or move up to 10 pounds and occasionally up to 50 pounds
● The Valdosta facility has a no smoking / tobacco / e-cigarette policy
Under This Roof, We Require
● High school diploma required
● Minimum 3 years quality experience in a fast paced, manufacturing environment
● Experience supporting production and business goals
● Demonstrated experience working in a customer-focused and multi-functional team environment
● Proficiency in Google Suite and other computer platforms
Under This Roof, We Also Value
● Associates or BS degree in Science or Engineering is preferred
● Demonstrated experience as a lab technician in a manufacturing environment is preferred
● Independent problem-solving and project management skills
How We Protect What Matters Most
● We offer a wide range of health insurance options that include medical, dental, and vision for you and your family.
● Our Family-Building benefits support the many different journeys to fertility and parenthood.
● Our robust 401K plan includes an employer match contribution with your pre-tax and/or Roth contributions.
● Other exciting programs and perks are available to help employees achieve work-life balance, including (but not limited to) a wellness program, free financial coaching, a referral program, and product rebates when purchased for an employee’s primary residence.
● Professional growth and development are very important to us! We offer internal training programs and courses, as well as a generous tuition reimbursement program.
● We put diversity and inclusion into action with our Employee Resource Groups, which unite employees based on common perspectives, identities, demographic factors, or out of a desire to be an ally.
GAF complies with federal, state, and local disability laws and makes reasonable accommodations for applicants and employees with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact HR Services at 833-HR-XPERT.
We believe our employees are our greatest resource. We offer competitive salary, benefits, 401k, and vacation packages for all full time permanent positions. We are proud to be an equal opportunity workplace and GAF, Standard Logistics, SGI, and Siplast are proud to be affirmative action employers. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know. If applying for positions in the U.S., must be eligible to work in the U.S. without need for employer sponsored visa (work permit).Official account of Jobstore.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
You’ll also have access to:
Our location in Temecula, CA currently has an opportunity for a QC Inspector I
The Opportunity
This position works out of our Temecula, CA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
WHAT YOU'LL DO
Job Summary:
Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures.
Job Duties:
• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Records inspection and test data as prescribed by written instructions and procedures.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Performs other related duties and responsibilities, on occasion, as assigned.
Equipment:
May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
Working Conditions:
Works in an air-conditioned clean-room manufacturing environment; requires gowning attire and hair/beard covers to maintain a particle free environment. Low to moderate noise level. Minor exposure to chemicals. May work at a desk or workstation.
Minimum Experience / Training Required
WHAT WE OFFER :
At Abbott, you can have a good job that can grow into a great career.
We offer:
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$15.00 – $30.00/hourIn specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Official account of Jobstore.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
You’ll also have access to:
Our location in Temecula, CA currently has an opportunity for a QC Inspector I
The Opportunity
This position works out of our Temecula, CA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
WHAT YOU'LL DO
Job Summary:
Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures.
Job Duties:
• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Records inspection and test data as prescribed by written instructions and procedures.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Performs other related duties and responsibilities, on occasion, as assigned.
Equipment:
May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
Working Conditions:
Works in an air-conditioned clean-room manufacturing environment; requires gowning attire and hair/beard covers to maintain a particle free environment. Low to moderate noise level. Minor exposure to chemicals. May work at a desk or workstation.
Minimum Experience / Training Required
WHAT WE OFFER :
At Abbott, you can have a good job that can grow into a great career.
We offer:
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$15.00 – $30.00/hourIn specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Official account of Jobstore.
Nature and Scope
The QC Particulate Scientist II will demonstrate proficiency in advanced techniques and expertise with particle isolation, manipulation and particle forensics supporting product investigations, process evaluation, examination of customer complaint CRU, source particle characterization and mitigation programs, and R&D container closure studies and will play a supporting role in method development, creation and certification of test sets, and routine analyses for product release by USP <788> & <790>.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Physical Environment and Requirements
Expected salary range:
$76,000 - $80,000
The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
Official account of Jobstore.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Our location in Temecula, CA, currently has an opportunity for a QC Inspector III - 2nd Shift.
The Opportunity
This position works out of our Temecula, CA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
What You’ll Work On
WHAT YOU'LL DO
The inspector provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work or material meets the division's quality system requirements.
MAIN RESPONSIBILITIES
Minimum Experience / Training Required
Education: High School Diploma / GED or an equivalent combination of education and work experience Associates Degree Preferred
Experience/Background
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$16.53 – $33.07/hourIn specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Official account of Jobstore.
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients. Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.
As an Associate scientist, your strong foundation in general scientific practice and in the principles and concepts of the discipline will help us achieve our goals. You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge.
It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture
Performs tasks associated with maintaining GMP compliant Quality Control and Stability laboratories.
Physical/Mental Requirements
Non-Standard Work Schedule, Travel, or Environment Requirements
Other Job Details:
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Official account of Jobstore.
Nature and Scope
This position provides support of the QC Microbiology and Environmental Monitoring Laboratories, to provide timely assistance to the microbiologists and leadership staff in the laboratory, ranging from basic cleaning, clerical duties, ordering supplies, preparation of media and reagents, sterilizing of supplies for testing, inventory management, and decontamination of biological waste.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Physical Environment and Requirements
Expected hourly rate:
$17.88 - $21.00
The hourly rate displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
Official account of Jobstore.
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.
Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.
As a Scientist, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
Able to create, review, and approve compliant test methods and training materials.
Perform tasks associated with maintaining Current Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
Support preparation of reagents, receipt, storage and handling of reagents.
Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.
Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects
Perform various inspections of laboratories and surrounding office area as assigned and prepare a report.
Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.
Train junior colleagues and may develop training plans and/or oversee training activities for groups.
Applicant must have HS diploma with 8 years of relevant experience; OR an Associate's degree with 6 years of experience; OR a Bachelor’s degree with at least 3 years of experience; OR a Master’s degree with more than 1 year of experience.
Technical Skills Experience in Analytical instrumentation and testing in Pharma or Biotech industry
Experience with HPLC troubleshooting in Pharma or Biotech industry
Understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
Detail oriented with Quality systems knowledge
Knowledge of research unit clinical and analytical Laboratory environment
Excellent effective written and verbal communication and interpersonal skills
Ability to work in a team environment
Knowledge of computer system hardware, infrastructure and networks
Empower experience
Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
Minimal off shift coverage may be required.
Last day to apply: October 9th, 2023
Employee Referral Bonus eligible
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. You will also be relied on for setting requirements for the transfer of methodology from R&D.
You will be developing and applying your knowledge of procedures, techniques, tools, materials and equipment. Your receptiveness to new ideas will enhance the team’s ability to achieve goals and targets. You will follow standard procedures to complete tasks and identify process issues or problems that involve direct application of your skills/knowledge.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
ROLE SUMMARY
This position is for a testing analyst in the Kalamazoo QO Raw Materials Laboratory working on first shift. Opportunity for schedule flexibility exists as the Laboratory supports business and customer needs on weekends and holidays. Technologies employed in the Raw Materials Laboratory include Physical Chemistry Testing, Wet Chemistry Testing, UV, ICP-MS and Atomic Absorption Testing.
ROLE RESPONSIBILITIES
Works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze in-process materials, raw materials, APIs, and/or finished product samples in direct support of the company's production units. Independently performs testing and documents results for qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation. Troubleshoots test methods and analytical equipment. Participates in laboratory investigations as required.
BASIC QUALIFICATIONS
Education:
High School Diploma or GED and at least 3 years of relevant experience in quality or compliance required. Candidates with advanced science degrees and relevant experience may also be considered as follows: Associate’s degree in Chemistry, Biochemistry or related science degree with at least 2 years experience in related field or Bachelor´s degree in Chemistry, Biochemistry or related science with 0-1 years of experience in related field.
Technical Experience:
Demonstrated proficiency in at least one high complexity technology (e.g. AA, ICP-MS, HPLC, uHPLC, GC, etc.) or, with two or more low to medium complexity technologies (e.g. TLC, titrations, wet chemistry/physical testing, water testing, etc.) as required by the business unit.
The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques.
High productivity and the ability to multi-task coupled with a low error rate and attention to detail.
Must demonstrate flexibility/agility and engagement in a changing environment.
The candidate is expected to display good laboratory technique to avoid cross-contamination or misidentification of samples.
Experience troubleshooting test methods and analytical instrumentation
PHYSICAL/MENTAL REQUIREMENTS
Laboratory and office work requiring walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position may require colleagues to work weekends and/or holidays to meet business or customer needs. All Laboratory colleagues adhere to safe work practices such as wearing appropriate personal protective equipment including lab coat, safety glasses, and gloves. There is no routine travel associated with this position.
OTHER JOB DETAILS
Last Date to Apply for Job: 09/28/2023
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Official account of Jobstore.
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
PHYSICAL/MENTAL REQUIREMENTS
Laboratory and office work requiring walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a Monday through Friday first shift position. Occasional weekday or weekend overtime may be required.
OTHER JOB DETAILS
Last Date to Apply for Job: 09/29/2023
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Official account of Jobstore.
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The Quality Control Analytical group is seeking a highly motivated and experienced candidate to support GMP analytical non-testing activities for the Raw Materials group at the Andover site. This candidate is responsible for writing , procedures, test methods, technical documents investigation reports, raw material specifications and change controls.
This position requires working collaboratively with the QC raw materials team (QC Analytical, QC Micro, Quality Assurance, Warehouse, Supply Chain and Site Technical Services).
This candidate will actively participate in scheduling, visual management, metrics, and continuous improvement activities. The successful candidate will be team oriented, have a passion for excellence, act with integrity, demonstrate equity and inclusivity, seek continuous improvement opportunities, actively participate in site recognition programs and take pride in his or her contribution to the team.
Writing and reviewing technical documents such as raw material specifications, standard operating procedures, test methods investigations and change controls.
Represent Quality Control Analytical in cross functional and site product meetings.
Support internal and external audits.
Plan and prioritize assignments
Perform analytical documentation activities of raw material samples.
Record and maintain all related data and records in compliance with cGMP and quality procedures.
Meet all timelines and deliverables in the support of the plan of record.
Support atypical or out-of-specifications test results, participate in investigations for resolution and correction.
Review data and documents for compliance and accuracy.
Participate in continuous improvement culture within the raw materials group. Utilize continuous improvement tools.
Participate and use 5S, standard work, and visual management tools and processes.
Perform work consistent with Pfizer Values of Courage, Excellence, Equity, and Joy
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate's degree with 6 years of experience OR a bachelor's with at least 3 years of experience OR Masters with more than 1 year of experience.
Experience working in QC testing laboratory in GMP environment in pharmaceutical industry.
Knowledge and practical application of relevant analytical techniques (raw material testing, wet chemistry testing, analytical testing)
Strong technical writing skills, including investigations
Demonstrated leadership skills in decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines
Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
Strong oral and written communication skills
Candidate must be self-motivated and be able to adapt to rapidly changing project priorities.
Experience with QC Raw Material testing and documentation
Knowledge and experience in cGMP USP/EP/JP, regulatory guidance and audits.
Experience with electronic document management systems and laboratory information management systems such as LIMS, SAP, PDocs, and Trackwise strongly preferred.
Experience authoring and reviewing QC documentation such as SOPs and test methods.
Experience authoring quality documents such as change controls, CAPAs, deviations.
Experience with DMAIC, lean, and continuous improvement tools desired.
PHYSICAL/MENTAL REQUIREMENTS
Normal lifting, sitting, standing, and walking requirements to facilitate testing in a laboratory environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.
Work Location Assignment: Flexible
OTHER JOB DETAILS
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Official account of Jobstore.
Avantor, a Global Fortune 500 company is looking for a dedicated QC Laboratory Validation Specialist to optimize our Quality Control Laboratory organization. This on-site/ Phillipsburg, NJ role is full-time.
If you have Quality Control Laboratory experience – let’s talk!
What we’re looking for:
Minimum Education Requirement: Bachelor’s degree in related field of study (IE: chemistry)
Required Experience (two + years):
Preferred Experience:
How you will thrive and create an impact:
You will:
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people’s lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom’s voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
Environmental Working Conditions & Physical Effort
Typically works in a laboratory environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers and others. Work assignments are diversified.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
EEO Statement:
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
Official account of Jobstore.
Nature and Scope
The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with and assists the manufacturing department, and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT I position is primarily responsible for performing environmental monitoring activities including water collection, air, surface and personnel monitoring within the sterile manufacturing facility.
Essential Duties and Responsibilities
Qualifications and Requirements
Physical Environment and Physical Requirements
Expected hourly range:
$22.50 - $24.50
The hourly range displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
Official account of Jobstore.
Official account of Jobstore.
