Quality Assurance Inspector II
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 when applicable to determine compliance with established specifications. The role also monitors manufacturing processes for compliance and receives, inspects, releases, and controls labels and outserts. The inspector ensures quality compliance before, during, and after each packaging run. The position performs quality inspections and testing throughout manufacturing and packaging, maintains detailed documentation, and prepares samples for laboratory analysis and retention. It also reviews batch and engineering records, verifies equipment functionality and environmental conditions, manages labeling components, and supports the proper control and disposition of materials and products.
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.
Responsibilities
- Perform inspection, sampling, and applicable testing of 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 applicable manufacturing stage.
- 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 inspection, and sampling.
- Prepare labeling-component and outsert inspection reports; quarantine and release labels; and maintain incoming-component logs 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 isolate quarantine, released, in-process, finished-product, packaged-product, returned-goods, 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 verify 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 materials and returned drug products according to SOPs.
- Perform environmental monitoring according to the established schedule when applicable.
- Perform applicable testing and prepare reports for customer complaints.
- Perform other duties assigned by management.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
