Senior Quality Assurance Inspector - 1st Shift
Amneal Pharmaceuticals · Brookhaven, NY · 3 wk ago
Quality Assurance$26–$31/hrFull-time
Responsibilities
- Monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for compliance with established specifications.
- Monitor and ensure all phases of drug manufacturing are in compliance with established specifications.
- Receive, inspect, release and control labels and outserts.
- Ensure quality compliance before, during and after each packaging run.
- Review engineering records (temperature and humidity data, calibration and PM records, pest control records, contractor‑related functions).
- Review online batch records for completeness of signatures, entries, and actual reconciliation/yields prior to initiation of the next processing step.
- Verify functionality of all equipment and associated controls during the batch run.
- Maintain retention sample room, monitor temperature and humidity, replace chart records per schedule, review logs and disposition of samples.
- Monitor and release of Purified Water System.
- Generate, proofread, and issue “in‑house” labels in accordance with Process Study protocols and master batch records.
- Perform rinse and swab sampling for microbial cleaning verification.
- Handle complaint samples: visual inspection, retention/complaint samples; review batch records for receipt of complaint batches; collect complaints/retention samples for analytical testing during complaint investigations.
- Identify gaps in manufacturing and packaging equipment and assess impact on product quality.
- Coordinate with manufacturing and engineering teams to resolve compliance issues in a timely manner.
- Perform other duties as assigned by management.
Qualifications
- High school diploma or GED required.
- Minimum 3 years of experience in QA or a related field.
- Successful completion of an OSHA‑compliant respirator fit test.
Pay
The hourly base salary for this position ranges from $26.00 to $31.00 per hour; individual compensation will be based on qualifications, geographic location, and other relevant skills.
Benefits
Amneal offers a comprehensive, flexible and competitive benefits program that includes above‑market health and insurance options, a significant 401(k) matching contribution, and employee well‑being programs to support career and life commitments.
Schedule
Schedule: 1st Shift, 7:00 am – 3:30 pm, Monday to Friday.