Senior QA Inspector — Pharma Compliance & Packaging

Operations

Town of Brookhaven (NY)

On-site

USD 65,000 - 90,000

Full time

6 days ago

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Job summary

Operations in the Town of Brookhaven area seeks a QA Inspector II to monitor sampling, testing, and labeling compliance across manufacturing processes. You will review batch records, calibration logs, pest control records, and contractor functions to ensure GMP compliance before, during, and after packaging runs.

Strong collaboration with manufacturing is essential. Requires at least 3 years in QA and a high school diploma or GED.

Qualifications

3+ years in QA or related field

Responsibilities

Monitor and sample incoming materials, packaging components and returned goods for compliance.
Ensure compliance of all drug manufacturing phases with established specifications.
Receive, inspect, release and control labels and outserts.
Ensure quality compliance before, during and after each packaging run.
Review engineering records and online batch records for signatures and reconciliation.
Verify functionality of equipment and controls during batch runs.
Maintain retention sample room and monitor temperature/humidity.
Generate and proofread in-house labels per master batch records.
Perform rinse and swab sampling for microbial verification.
Handle complaint samples and batch records for investigations.
Identify gaps in manufacturing/packaging equipment and assess impact.
Coordinate with manufacturing and engineering to resolve compliance issues.
Other duties as assigned.