Quality Assurance Inspector II - 2nd Shift

Amneal•Yaphank, NY

2d•$21 - $27

About The Position

The Quality Assurance Inspector II monitors and ensures that incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested as applicable for compliance with established specifications. The role monitors compliance with specifications throughout drug manufacturing and packaging, and receives, inspects, releases, and controls labels and outserts. It ensures quality compliance before, during, and after each packaging run. The position performs inspections, sampling, testing, and documentation; prepares samples for the QC laboratory; conducts room, equipment, packaging-line, and in-process checks; and reviews manufacturing documentation. It also manages labeling components, supports warehouse material segregation, monitors environmental conditions, maintains retention samples, and performs additional quality activities such as complaint testing and reporting.

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 when required 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 activities.
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 each manufacturing stage, as 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; perform visual examinations, counting, preliminary inspections, and sampling.
Prepare labeling-component and outsert inspection reports; quarantine and release labels; and maintain the incoming-components log and inventory cards.
Issue labeling components and outserts according to packaging orders and regularly 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 properly segregate quarantined, released, in-process, finished, packaged, returned, and rejected materials.
Ensure rejected material generated during batch processing is properly isolated and accounted for in the batch record.
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 the functionality of equipment and associated controls during batch runs.
Maintain the retention-sample room; monitor temperature and humidity; replace chart records on 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.
Perform other duties assigned by management.