Quality Assurance Inspector II

Role Summary

Quality Assurance Inspector II is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested to determine compliance with established specifications. The role also ensures compliance across all phases of drug manufacturing, handling labels and outserts, and maintaining quality before, during, and after packaging runs.

Responsibilities

• Perform inspection, sampling, and testing on all incoming raw materials, packaging components, and returned goods following detailed written procedures.
• Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab.
• Inspect and test packaging components using measuring devices (scales, micrometers, height gauges) to determine conformance to specifications.
• Maintain detailed records of sampling, inspections, and testing activities.
• Assign and verify expiry and retest dates for GMP raw materials through vendor COA and in-house COA.
• Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks prior to stages of manufacturing following procedures.
• Conduct in-process testing per manufacturing and packaging batch record instructions.
• Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains following documentation procedures.
• Maintain standard weights for daily balance verification; handle labeling components receipt, visual examination, counting, and sampling.
• Prepare labeling components/outserts inspection reports; quarantine and release labels; maintain incoming components log and inventory cards.
• Issue labeling components/outserts according to packaging orders; monitor and audit label room.
• Complete QA final labeled product inspection report and final line clearance including labeling and packaging reconciliation.
• Ensure warehouse area is properly isolated and managed (Quarantine, Released, In-Process, Finished, Packaged, Returned, Rejected).
• Ensure proper isolation of rejected material and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review engineering records (temperature/humidity data, calibration/PM records, pest control, contractor functions).
• Review online batch records for completeness of signatures and entries; ensure reconciliation/yields prior to next processing step.
• Verify functionality of equipment and controls during the batch run.
• Maintain retention sample room and monitor temperature/humidity; manage chart records and sample disposition.

Qualifications

• High School or GED - Required
• 2 or more years experience in QA or related field

Skills

• High energy level and strong organizational skills
• Creativity and latitude in approach
• Basic computer skills (Word and Excel)

Education

• High School or GED - Required

Additional Requirements

• OSHA-compliant Respirator Fit Test required