Quality Assurance Inspector II - Night Shift

About the role

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.
• Maintain 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.
• Congduct 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.
• Filling 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.
• 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.
• Maintenance of retention sample room and monitoring of temperature and humidity, replacement of 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).
• Performs applicable testing and prepare report for customer complaints.

Qualifications

• Education: High School or GED - Required
• Experience: 2 years + experience in QA or related field
• Specialized Knowledge: Good basic math knowledge and excellent attention to details. Records observations for improving processes.

Pay

The hourly rate for this position ranges from $20.00 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.

Schedule

N/A

Benefits

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.

About Us

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.