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Nature and Scope
This position in the Sterility Assurance Department will be primarily responsible for writing investigations/Excursions for Environmental and Personnel Monitoring with regards to assurance of sterility and being involved in technical projects from protocols to final reports.
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.
Write technical protocols and reports for studies, trend reports, etc.
Perform investigations for out-of-specification (OOS) or out-of-trend (OOT) when requested.
Plan daily workload to meet requirements.
Report any issues with Aseptic Technique or cGMP compliance to Sterility Assurance Management.
Work independently with minimal supervision.
Manage Corrective and Preventive Actions (CAPAs) and ensure closure in a timely manner.
Initiate Change Controls to procedures requiring modifications.
Completing gowning qualifications to enter the Aseptic Processing Areas (APA).
Addresses any problems that arise and bring quality issues to Management attention.
Perform any other tasks/duties as assigned by management.
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.
Bachelor’s Degree in Microbiology, Biology or related field required.
Minimum one-year experience in QC Microbiology, Environmental Monitoring or Sterility Assurance within the pharmaceutical industry, food industry, cosmetics, medical devices, Laboratory Pathology or similar FDA regulated environment, required.
Knowledge of Aseptic Technique / Clean Room Experience preferred.
Technical writing skills required.
Organized individual with strong attention to detail.
Excellent communication skills (oral and written).
Proficient in Microsoft Office.
Proficient in Trackwise and MODA/LIMS or equivalent software or equivalent preferred.
Good work ethic and highly motivated.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Physical Environment and Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
Job activities require long periods of sitting and/or standing per assign duties.
Employee must be able to occasionally lift and/or move up to 25 pounds.
Expected salary range:
$68,500 - $72,000
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.
Nature and Scope
This position will provide a comprehensive Quality compliance review of Environmental Monitoring data in LIMS (Laboratory Information Management System) & logbooks, cGMP Microbiology Lab analytical data & results for raw materials, in-process and finished product release, stability program results and summaries data related to the Validation of pharmaceutical processes. To facilitate corrections and clarifications to the reviewed data and provide a final approval of the records.
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.
Provides quality assurance review of laboratory raw data and reports including environmental monitoring and microbiological worksheets, test summaries, and trending data (for microbiological related data).
Communicates any audit comments/ observations/ findings during review to respective stakeholders and get them corrected
Informs the supervisors/manager immediately of any critical data integrity issues or data irregularity.
Participates in identifying quality process improvements to increase efficiency and performance of systems, operations and personnel relating to the QA Data Review process.
Writes and revises SOP’s and other GMP (Good Manufacturing Practices) documentation as needed. Initiate and complete Change Request process.
Ensures compliance with cGMP/cGLP and good documentation procedure during the review process
Follow SOPs (Standard Operating Procedure) and Safety Guidelines to ensure compliance within a cGMP environment.
Extend help in collecting EM/PM data for investigation and author Investigation.
Ensures all work is performed and documented according to existing Company policies and procedures, cGMP, compendia, and all applicable FDA (Food and Drug Administration) Guidance document requirements. Perform cGMP training for department.
Participates in other Quality System activities with other team members as needed.
Perform any other tasks/duties as assigned by management.
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.
Bachelor’s degree in the Biological, Physical Sciences, Mathematics, or related field, or Associate's Degree with 2 years experience in data review within a laboratory setting, required.
Minimum 2 years of microbiological experience (i.e. gram stains, plate counts, manufacturing of media, environmental monitoring, and microbiological assays) or at least 1 year of data review experience within a laboratory setting.
Demonstrates extreme attention to detail to achieve quality results.
Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines.
Exercises a willingness to learn and participate in added responsibilities as needed.
Excellent organizational, interpersonal, and communication skills (oral and written) to work in a team environment.
Ability to work overtime as needed.
Expected Hourly Rate:
$37.55-$39.50
The hourly rate displayed is the hourly rate of compensation 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.
Nature and Scope
The packaging order handler performs an essential part of the serialization process. Serialization assigns a unique serial number to drug products in the form of a 2-D bar code for the purposes of tracking the product through each stage of the manufacturing and packaging process. The incumbent will be trained and then must fully understand the operation of the Optel bar coding system and equipment, and perform related functions including bar code scanning and computer system verification. The incumbent interacts with multiple levels of employees in manufacturing and quality assurance and follows all relevant Current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs.)
Essential Duties and Responsibilities
Perform pack/scan operations using 2-D bar code scanning technology.
Navigate computer systems to verify scanned products.
Troubleshoot bar code systems to aggregate/disaggregate trays/shippers as necessary.
Communicates issues and problems to supervision in a timely manner.
Perform adjustments to Zebra label machines, (including loading new rolls of labels and print adjustments as needed).
Print serialized pallet tags upon completion of completed skids.
Move product from packaging line to warehouse using floor jacks/power jacks.
Shrink wrap skids as needed.
Properly disposes of refuse and waste.
Accurately completes all documentation associated with tasks performed, including printed closeout paperwork of packaged jobs.
Keeps work area clean and orderly.
Follow directives issued by leads and supervisors.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
High School Diploma or Equivalent, required.
Demonstrated proficiency with computer systems and programs.
Experience with the operation of bar code 2-D scanning, preferred.
Effective oral and written English communication and basic math skills.
Ability to read and comprehend policies, procedures and operating instructions.
Ability to work effectively as part of a team.
Adheres to good manufacturing practices (GMP & cGMP).
Perform duties according to the company’s standard operating procedures, (SOPs).
Ability to work overtime as needed.
Physical Environment and Requirements
Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
Able to stand for extended periods.
Able to lift 11-25 pounds repeatedly (5 to 6 hours). Able to lift up to 50 pounds occasionally (1-2 hours).
Expected Hourly Rate:
$24.98
The hourly rate displayed is the hourly rate of compensation 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.
Nature and Scope
Regulatory submissions/operations professional with experience in complete pharmaceutical development life-cycle management. The focus of this position will be to ensure publishing compliance to FDA, EU and Health Canada regulations. Focus on delivery with excellence while maintaining quality and compliance.
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.
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.
Nature and Scope
This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting company goals. The Team Member will be able to participate in all aspects of the Manufacturing Process.
The Manufacturing Process includes semi-automatic loading of glass vials, caps and seals into manufacturing machinery, semi-automatic unloading of finished product from the manufacturing machinery and the set-up/tear down and line clearances of the manufacturing equipment. The manufacturing technology utilized at American Regent – New Albany includes HMI-PLC/SCADA controlled Isolation Barrier Filling, Autoclave Sterilization, VHP Sterilization, CIP Sanitation, SIP Sterilization and Lypholization. The Team Member will assist with all activities associated with the manufacturing process under the direct supervision of Senior Manufacturing Team Members.
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.
· Gathers, stages and returns production materials in support of manufacturing activities.
· Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing.
· Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
· Staffs various stations in support of container washing, filling, stoppering, and capping. Will offload finished product.
· Attends all training programs as required by Company SOPs, policies, and procedures.
· Perform any other tasks/duties as assigned by management.
Qualifications and Requirements
· High School Diploma or GED preferred. Some college or technical training is a plus.
· Minimum 2 years work experience in a related field preferred.
· Ability to perform basic mathematical calculations.
· Possesses mechanical aptitude with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
· Ability to stand in one place for prolonged periods of time, monitoring equipment and processes.
· Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
· Ability to work overtime as needed.
Physical Environment and Physical Requirements
· Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
· Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
· Employee must be able to occasionally lift and/or move up to 50 pounds.
· Physically able to work using isolation containment devices.
· Physically able to stand for long periods of time.
· Ability to meet and maintain cleanroom gowning requirements.
· Ability to meet and maintain respirator fit-testing requirements.
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.
The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform manual inspection and train in the automatic inspection/packaging area for setup, of automated equipment and manual inspection processes, labeling and packaging equipment duties, line clearances and assist with inspection/packaging schedule. In conjunction with the Supervisor, the Technician plays a critical role in assuring safe, effective and compliant activities are performed in the manual inspection process while maintaining production schedules. The Equipment and Process Technician I will be proficient in all activities associated with the inspection process and be able to work with minimal supervision. The Technician will receive direction, training and mentorship from the Supervisor of Inspection and Packaging.
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.
• Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor.
• Maintains accurate and complete records.
• Maintains an accurate and complete Training Record.
• Ability to set-up Manual Inspection process with little to no assistance.
• Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities.
• Physically performs inspection reconciliation and provides documentation oversight and acknowledgement for such activities.
• Ability to review executed batch records and log books prior to submitting for final Production review.
• Provides accurate and complete assistance to Quality Assurance as needed.
• Works in a safe and effective manner.
• Identifies and reports unsafe and non-compliant conditions.
• Maintains work space in a clean and orderly manner.
• Perform any other tasks/duties as assigned by management.
• We all must embrace the QUALITY culture.
QUALIFICATIONS AND REQUIREMENTS
• High School diploma or GED preferred. Some college or technical training is a plus.
• Minimum 1-year work experience in inspection, packaging, quality control and/or production preferred.
• Must be able to work independently, completing assigned tasks with limited supervision.
• Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.
• Excellent organizational, interpersonal and communication skills (oral and written).
• Ability to take feedback constructively and consider the viewpoints of others.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.
PHYSICAL ENVIRONMENT AND PHYSICAL REQUIREMENTS
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
• Must be able to sit for extended hours, focusing and concentrating on items being inspected.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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.
Nature and Scope
This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management, the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting company goals.
The Team Member will be able to participate in all aspects of the Filling Process. The Filling Process includes dispensing components, cleaning, assembling, and sanitizing small and large pieces of equipment, and aseptic filling in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals. The Filling Process includes loading of glass vials, stoppers, caps, and seals into manufacturing machinery, operation of filling machine, operation capping machine, unloading of finished product from the manufacturing machinery and the line clearances of the manufacturing equipment. The Filling Operator I will assist with all activities associated with the filling process under the direct supervision of a Filling Operator II-III, Lead and/or supervisor.
Essential Duties and Responsibilities
Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures.
Adheres to good manufacturing practices, (GMP & cGMP).
Perform duties according to the company’s standard operating procedures, (SOPs).
Operates washer and capper machines used in department. Accurately counts work done and keeps necessary records.
Trays on containers and off loads work in process [WIP] to support filling windows.
Cleans work areas as needed and documents in appropriate lob book.
Notifies supervisor or lead person of any problems.
Accurately completes all documentation associated with tasks performed.
Stocks, gathers and stages manufacturing supplies and equipment.
Gathers, stages and returns production materials as required to support manufacturing activities.
Cleans and stores manufacturing equipment and areas as required to support manufacturing activities.
Sanitization/disinfection of components, materials and production supplies to support the manufacturing process.
Required to become gown qualified, maintain training status and wear gamma irradiated garments consisting of a coverall, hood, mask, gloves, boots and goggles.
Required to become qualified cleaner for the aseptic processing area.
Attends all training programs as required by Company SOPs, procedures and policies.
Perform any other tasks/duties as assigned by management.
Keeps work area clean and orderly.
Education Requirements and Qualifications
Minimum of high school diploma or GED preferred.
Able to pass gowning qualification and Media Fill Qualification.
Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment preferred.
Ability to take feedback constructively and function in a team oriented work environment.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Ability to work overtime as needed.
Must become qualified to don Glass Washroom and APA gowning apparel.
Must become qualified to perform Glass Washroom and APA cleaning.
Must become qualified to operate washers and cappers.
Must become qualified to operate aseptic fill room independently.
Physical Environment and Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, masks, and protective gloves. PPE are essential for the health and safety of employees.
Employee must be able to repeatedly lift and/or move up to 25 pounds.
Employee must be able to stand for extended periods of time.
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.
Nature and Scope
The Equipment and Process Technician II works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform inspection area setup of automated equipment and manual inspection processes, labeling and packaging equipment and process duties, line clearances and assist with inspection/packaging schedule.
The Technician will be responsible for maintaining inspection and packaging equipment for changeover and adjustments. In conjunction with the Supervisor, the Technician will provide input and assistance to other Departments as needed. The Technician plays a critical role in assuring safe, effective, and compliant activities are performed in the inspecting and packaging area and plays a critical role in maintaining production schedules. The Equipment and Process Technician II will be proficient in all activities associated with the inspection and packaging process and be able to work with minimal supervision.
The Technician will receive direction, training, and mentorship from the Supervisor of Inspection and Packaging. The Technician will, with assistance from the Supervisor, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Technician will be able to select parameters requiring Supervisor Approval from some manufacturing technologies using the HMI-PLC/SCADA control/data systems.
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
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.
Nature and Scope
As a Lean Specialist, you’ll play a pivotal role in channeling our manufacturing capabilities to make a positive impact within the organization. As part of a larger team, you’ll provide technical and leadership belt mentoring, along with project support as required for internal Lean Six Sigma initiatives and Operational Excellence initiatives.
This individual will Lead/Coordinate/Design team promotional efforts including department and organizational awareness. The successful candidate will support/lead project teams and strategic initiatives, assist in developing and delivering training activities as it relates to lean projects, document revisions and implementation. This individual will oversee document changes not limited to Lean, using Veeva, Trackwise change control system(s) and provide tracking and trending key performance indicators (KPI’s).
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.
• Ability to manage and lead project specific meetings.
• Oversee the creation, revision, and development of documents, including the change control process.
• Ability to create and define new process procedures relative to new production equipment.
• Works cross-functionally with other departments and sites to complete tasks and overall project timelines.
• The ability to create, revise and execute documents using Veeva and Trackwise Operating Systems.
• Support projects, evaluate, lead, and develop improvements to operational processes.
• Leveraging cross-functional departments within the organization to optimize success and build meaningful relationships across teams.
• Plan and participate in the execution of project initiatives defined in terms of ROI, assuming direct assignments as part of each project plan.
• Directs and facilitates the ongoing lean improvement process utilizing lean and project management techniques.
• Identify lean improvement training needs and assist with developing and implementing the required training.
• Establish measurable standards at the start of a project and then compare actual project results against these, regularly generating detailed update reports for management.
• Provide regular updates to the Leadership team on progress, key milestones, and roadblocks to successful project implementation.
• Be an effective communicator with operational leadership, key operators, and other production influences.
• Able to apply problem-solving techniques to complex problems.
• Establish work measurement programs and analyze work samples to develop labor utilization standards.
• Discuss with engineering staff and management to plan and suggest potential projects and initiatives. Observe value stream waste, coach, and drive Lean principle and methodologies for waste removal.
• Provide support to the department in relation to CAPA development, progression, and closure.
• Perform any other tasks/duties as assigned by management.
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.
• High School Diploma or GED equivalent required. Bachelor’s degree preferred.
• 3+ years’ experience working in a Manufacturing environment required.
• Lean Six Sigma Green Belt training or certification preferred.
• Experience with Lean concepts required.
• Ability to manage multiple projects at any given time.
• Strong organizational skills with the ability to prioritize and adapt.
• Exceptional communications skills (oral, written and presentation) and situational leadership abilities.
• Ability to work collaboratively with key stakeholders.
• Proficient in computer/technical literacy, with strong Microsoft Office Suite skills.
Physical Environment and Requirements
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
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.
Nature and Scope
This position is a member of the Logistics Department. The Logistics Department is responsible for warehouse activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. This position is a member of the Logistics Department. The Logistics Department is responsible for warehouse activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. In conjunction with Production Management, the Logistics Department provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. Receive materials (both inventory and non-inventory items), put away materials in rack locations. Pull and stage materials for production.
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
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.
Nature and Scope
This entry-level position is a member of the Autoclave area under the Inspection Department, who comprise a portion of the Manufacturing Team. This position will be expected to execute the required responsibilities and tasks necessary to perform as an Autoclave Operator using current Good Manufacturing Practices (cGMP) according to approved SOP’s in order to support the overall mission of the Manufacturing Team.
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.
Loads and unloads trays and carts into sterilizers.
Operates steam sterilizers, (autoclaves).
Monitors recording devices and initiates corrective action.
Records data onto charts, batch records and logbooks.
Transports product.
Cleans and performs maintenance checks on the sterilizers according to Standard Operating Procedures (SOP’s).
Performs housekeeping duties in and around Autoclave areas.
Operates Autoclaves according to SOP.
Performs other related duties as requested by lead or supervisor.
Perform any other tasks/duties as assigned by management.
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.
High School Diploma or Equivalent, required.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Ability to work independently.
Ability to work overtime as needed.
Physical Environment and Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
Employee must be able to occasionally lift and/or move up to 50 pounds.
Must be able to stand for prolonged periods of time while fulfilling job duties.
Expected Hourly Rate:
$19.04
The hourly rate displayed is the hourly rate of compensation 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.
Nature and Scope
A Custodian has the primary responsibility of cleaning the facility and grounds in such a way as to promote a healthy and safe environment.
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.
Performs all types of cleaning throughout the building. Cleans, disinfects and restores bathrooms.
Buffs and mops floors, sweep, dust, mop, clean glass and vacuum floors.
Uses various floor care machines.
Stocks bathrooms and cafeterias with appropriate supplies.
Removes garbage and cardboard.
Remove soiled scrubs/uniforms from the 2nd floor male/female locker room laundry bins and transport soiled scrubs/uniforms to 1st floor holding bins.
Stock 1st floor APA outer Locker Room area with clean scrubs.
Prepares and uses various types of cleaning agents.
Performs miscellaneous outdoor cleaning chores, such as grounds keeping and snow removal.
Perform any other tasks/duties as assigned by management.
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.
High school diploma or equivalent, required. Vocational or trade school certification accepted.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Ability to work overtime as needed.
Physical Environment and Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
Employee must be able to occasionally lift and/or move up to 50 pounds.
Ability to transport 55-gallon drums through the facility.
Ability to work with outside contractors.
Ability to work independently.
Expected Hourly Rate:
$17.85
The hourly rate displayed is the hourly rate of compensation 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.
Nature and Scope
The Manual Inspector Trainee is an entry level position responsible for the manual inspection of our products using visual methods to detect particulates in vials, liquid volume, defects, etc. Trainees must pass a Visual Inspection Qualification Test and pass qualifications to operate automated inspection equipment before becoming an Inspection Machine Operator I.
Essential Duties and Responsibilities
Performs inspection of vial, ampoule, and syringe containers by hand (manually).
Accurately completes all documentation associated with tasks performed.
Keeps work area clean and orderly.
Follow directives issued by leads and supervisors.
Adheres to good manufacturing practices, (GMP & cGMP).
Perform duties according to the company’s standard operating procedures, (SOPs).
Education Requirements and Qualifications
High School Diploma or Equivalent required.
Must pass a Visual Inspection Qualification test within 89-day probationary period. This is a temporary position, in which candidate must complete the qualifications to become an Inspection Machine Operator I within 89 days.
Accurately read, write and count.
Able to work effectively with others.
Ability to work overtime as needed.
Physical Environment and Requirements
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
Able to stand and sit for extended periods.
Able to lift 10 pounds repeatedly (5-6 hours).
Able to lift 11-25 pounds occasionally (1-2 hours).
Expected hourly rate:
$17.85
The hourly rate displayed is the 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.
Title: QC Scientist IV
Job Location: 5 Ramsey Road, Shirley, NY 11967
DESCRIPTION
Duties: Coordinate Chemistry Laboratory testing to ensure that all required samples (raw materials, in process, and finished products) are received and tested. Monitor laboratory activities and achieve a smooth and timely operation. Conduct quality control tests. Communicate and give guidance to chemists and technicians where required. Maintain an adequate supply of inventory levels. Order supplies based on workload requirements. Review of testing and documentation as required. Assist in the operation, calibration, preventive maintenance, and troubleshooting of laboratory instruments to ensure proper working order. Update and/or create monographs/SOPs to meet current compendial regulations/specifications. Oversee/perform investigations as required of SOP and cGMP deviations in the Chemistry Laboratory. Provide technical assistance on new and existing products to other departments. Assist and write events, technical protocols (laboratory instrument IQ/OQ/PQ) and initiate change controls when necessary. Undertake or oversee special projects (ex: validation of new equipment and software, and introduction of new tests or procedures in the laboratory). Advise management as to new employee's proficiency on various stages of training; train new employees. Assist in supervisory duties in the absence of management. Perform any other tasks/duties as assigned by management.
The position hours are for third shift (11:00PM – 7:30AM, Sunday – Thursday). Due to several types of tests that are conducted in the course of this position, individuals must possess 20/20 vision (corrective lenses allowed) and be able to make decisions on color. As such, upon hiring, individuals will be required to provide evidence of possessing 20/20 vision (corrective lenses allowed) and must undergo Color Blindness Screening (D15).
Salary: $113,318 - $125,000
QUALIFICATIONS
Master’s Degree in Chemistry or related science, or foreign equivalent, and minimum of five (5) years of pharmaceutical laboratory experience. In addition, five (5) years of experience in the following is required:
Alternatively, the employer will accept a Bachelor’s degree or foreign equivalent in Chemistry or related science plus eight (8) years of pharmaceutical laboratory experience, as well as in the skills outlined above.
Please apply at https://www.americanregent.com/Careers
using Req. ID R-102170.
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, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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 contact John Rossini, Talent Acquisition Director at at jrossini@americanregent.com.
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.
Nature and Scope
As part of a team of Analytical Chemists, this position is responsible for performing the analytical activities necessary to support finished product and raw material groups.
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
While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
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.
If you don't have a Australian citizenship, but are living in Australia or if you are planning to move to Australia and are looking for jobs that can sponsor you, it is up to each individual employer on how it handles international candidates.
Have you tried following up? If you did not follow up with an email or phone call, how do you determine if the company received your job application? Enquire where they are in the review process and and then ask if they received your submission. While it would be great to receive a response from the company, sometimes it doesn’t happen. Take the initiative to follow to ensure your application has been received.
The period of the application process will vary, depending on the type of job you are applying for and your previous employment experience.
There are 6 position levels and each level can be associated with a salary range and different types of job titles. Jobs levels can be categorised into: non-executive, fresh/entry level, junior executive, senior executive, manager and senior manager.
Within Jobstore, there are hundreds of variations of jobs. Read through the job descriptions to find out about the typical responsibilities and employers for each job, so you can see what’s involved and who might employ you.
You can certainly obtain expertise without working in a certain sector full-time, albeit it may take a little extra work. And of course, there's nothing wrong with some good ol' networking.
One of the worst mistakes you can make, aside from the obvious ones like being late or using unprofessional language or being messy or unclean, is not being well-prepared.
Don't forget to bring all of the relevant resources, including your résumé, portfolio, and a notepad. You can also prepare your answers in advance by researching the company's industry, competitors, and CEO.
