Quality Assurance Inspector II

Amneal Pharmaceuticals; Branchburg Township (NJ); Sur place; USD 32 000 - 36 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC is seeking a QA Inspector I to monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested according to established specifications. You will also ensure packaging labels and outserts are controlled and that all GMP materials are released in compliance.

As part of the role, you will prepare samples for chemical and microbiological analyses, maintain detailed records, and verify expiry and retest dates.

Qualifications

• 2+ years of QA or related field experience.
• Strong math skills and attention to detail.
• Experience inspecting incoming raw materials and packaging components.

Responsabilités

• Inspect, sample and test incoming raw materials, packaging components and returned goods.
• Prepare samples for chemical and microbiological analyses.
• Inspect packaging components using scales, micrometers and height gauges.
• Maintain detailed records of sampling, inspections and testing.
• Assign and verify expiry and retest dates for GMP materials.
• Collect samples for annual stability.
• Conduct in-process testing per batch records instructions.
• Prepare QC/QA samples and reports as required.
• Maintain weights for daily balance verification.
• Labeling components/outserts inspection and log incoming components.
• Issue labeling components per packaging order; monitor label room.
• Fill final QA labeling and packaging reconciliation paperwork.
• Isolate and manage rejected materials and nonconforming items.
• Environmental monitoring per schedule.

Connaissances

QA inspection

Sampling & testing

Documentation

Label control

COA review

Formation

High School or GED

Outils

Scales

Micrometers

Height gauges

Description du poste

Description

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run.

Essential Functions

• All Functions of QA Inspector I, Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures.
• Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab.
• Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications.
• Maintaining detailed records of sampling, inspections and testing activities.
• Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA.
• Collection of packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures.
• Conduct in process testing per manufacturing and packaging batch record instructions.
• Prepare controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures.
• Maintenance of standard weights required to perform daily verification of balances.
• Labeling component receipt, visual examination, counting, preliminary inspection and sampling.
• Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards.
• Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room.
• Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork.
• Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.
• Plus the following:
  • Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)
  • Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
  • Verification of functionality of all the equipment and associated controls during the batch run
  • Maintenance of retention sample room and monitoring of temperature and humidity, replacement fo chart records as per schedule, review of log and disposition of samples.

Additional Responsibilities

• Disposition of rejected material and returned drug products as per SOP
• Performs environmental monitoring in accordance with established schedule (where applicable)
• Perform applicable testing and prepare report for customer complaints
• Other duties that management may from time-to-time assign.

Education

• High School or GED - Required

Experience

• 2 years or more in 2 or more years' experience in QA or related field

Specialized Knowledge

• Good basic math knowledge and excellent attention to details.
• Records observations for improving processes.

The hourly rate for this position ranges from $23.00 to $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.