Quality Assurance Inspector II - 2nd Shift

Amneal•Yaphank, NY

3d•$21 - $27

About The Position

The Quality Assurance Inspector II monitors incoming raw materials, packaging components, and returned goods to ensure they are sampled, inspected, and tested where applicable in accordance with established specifications. The role also monitors drug manufacturing for compliance with specifications, controls and releases labels and outserts, and verifies quality compliance before, during, and after packaging runs. The inspector performs inspections, sampling, and testing under written procedures; prepares samples for chemical and microbiological analysis and delivers them to the QC laboratory; conducts in-process testing; and maintains detailed records. The role includes inspecting packaging components with measuring devices, assigning and verifying GMP raw-material expiry and retest dates, collecting packaged-product samples for annual stability, and performing room, equipment, and packaging-line checks. Additional work includes managing labeling components and outserts, preparing inspection reports, quarantining and releasing labels, issuing components for packaging orders, monitoring and auditing the label room, completing final labeled-product inspections and line clearance, and maintaining appropriate segregation of warehouse materials and products. The inspector reviews engineering and online batch records, checks equipment functionality and environmental conditions, and maintains the retention sample room and its records. Other duties may be assigned by management.

Requirements

High school diploma or GED.
At least 2 years of experience in QA or a related field.
Good basic math knowledge.
Excellent attention to detail.
Ability to record observations for process improvement.
Successful completion of an OSHA-compliant Respirator Fit Test.

Responsibilities

Inspect, sample, and test incoming raw materials, packaging components, and returned goods according to written procedures.
Prepare samples for chemical and microbiological analysis and deliver them to the QC laboratory.
Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges.
Maintain detailed records of sampling, inspections, and testing.
Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house certificates of analysis.
Collect packaged-product samples for annual stability.
Perform room, equipment, and packaging-line checks before manufacturing stages, where applicable.
Conduct in-process testing according to manufacturing and packaging batch record instructions.
Prepare controlled, uncontrolled, and packaged finished-product samples for the QC laboratory and QA retains, following documentation procedures.
Maintain standard weights used for daily balance verification.
Receive labeling components; conduct visual examinations, counting, preliminary inspections, and sampling.
Prepare labeling-component and outsert inspection reports; quarantine and release labels; maintain incoming-component logs and inventory cards.
Issue labeling components and outserts according to packaging orders, and monitor and audit the label room.
Complete final labeled-product inspection reports and final line clearance, including labeling and packaging reconciliation paperwork.
Ensure warehouse areas appropriately isolate quarantined, released, in-process, finished, packaged, returned, and rejected materials or products.
Ensure rejected material generated during batch processing is properly isolated and accounted for in batch records.
Monitor facility and product environmental operating conditions.
Review engineering records, including temperature and humidity data, calibration and preventive-maintenance records, pest-control records, and contractor-related functions.
Review online batch records for complete signatures and entries and for actual reconciliation and yields before the next processing step begins.
Verify functionality of equipment and associated controls during batch runs.
Maintain the retention sample room; monitor temperature and humidity, replace chart records according to schedule, review logs, and disposition samples.
Disposition rejected material and returned drug products according to SOPs.
Perform environmental monitoring according to the established schedule, where applicable.
Perform applicable testing and prepare reports for customer complaints.
Complete other duties assigned by management.