Quality Assurance Inspector II

Role Summary

Quality Assurance Inspector II responsible for monitoring, inspecting, sampling, and testing incoming materials, packaging components, and finished goods to ensure compliance with established specifications across all phases of drug manufacturing.

Responsibilities

• All Functions of QA Inspector I, perform inspection, sampling and testing on incoming raw materials, packaging components, and returned goods following detailed procedures.
• Prepare samples for chemical and microbiological analysis and deliver to the QC lab.
• Inspect and test packaging components using measuring devices to ensure conformance to specifications.
• Maintain detailed records of sampling, inspections, and testing activities.
• Assign and verify expiry and retest dates for GMP raw materials via vendor COA and in-house COA.
• Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks prior to each stage of manufacturing.
• Conduct in-process testing per batch records.
• Prepare finished product samples for QC/QA retains following documentation procedures.
• Maintain standard weights for daily balance verification.
• Receipt, visual examination, counting, preliminary inspection, and sampling of labeling components/outserts; quarantine and release labels; maintain inventory logs.
• Issue labeling components/outserts according to packaging orders; monitor label room.
• Complete QA final labeled product inspection reports and final line clearance including packaging reconciliation.
• Ensure warehouse isolation of Quarantine, Released, In-Process, Finished, Packaged, Returned, and Rejected areas.
• Isolate rejected material and ensure accountability in batch records; monitor environmental conditions.
• Review engineering records and online batch records for completeness and reconciliation prior to next step; verify equipment functionality during batch runs.
• Maintain retention sample room and monitor temperature/humidity; manage chart records and sample disposition.

Qualifications

• Education: High School or GED - Required
• Experience: 2 years or more in QA; 2 years in pharmaceutical industry - Required

Skills

• High energy level and organizational skills (Advanced)
• Creativity and latitude (Advanced)
• Basic computer skills (Word and Excel) (Intermediate)

Education

• High School or GED

Additional Responsibilities

• Disposition of rejected material and returned drug products per SOP
• Environmental monitoring per schedule (where applicable)
• Perform testing and prepare reports for customer complaints
• Other duties as assigned by management