Quality Assurance Inspector

Role Summary

Quality Assurance Inspector responsibilities include monitoring and ensuring all incoming raw materials, packaging components and returned goods are sampled, inspected and tested to determine compliance with established specifications, and ensuring all phases of drug manufacturing comply with specifications, including receive, inspect, release and control of labels and outserts to ensure 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 and deliver to the QC lab. Inspect and test packaging components using measuring devices 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 and in-house COAs. Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks prior to each stage of manufacturing following procedures. Conduct in-process testing per manufacturing and packaging batch records. Prepare samples for QC lab and QA retention following documentation procedures. Maintain standard weights for daily balance verification.
• Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Prepare labeling components/outserts inspection reports; quarantine and release labels and maintain incoming components log and inventory cards. Issue labeling components/outserts according to packaging orders and monitor label room. Complete the QA final labeled product inspection report and final line clearance paperwork.
• Ensure warehouse area compliance with isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
• Ensure proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.

Additional Requirements

• Operate, maintain and calibrate hardness tester, friabilator, weight variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters; maintain calibration records.
• Collect samples to reassay bulk finished product before expiration.
• Work in a contained manufacturing area/facility following all precautions and procedures.
• Visual inspection and preparation of reports of all products for APR.
• Other duties as assigned by management.

Education

• High School or GED - Required

Experience

• 1 year or more in QA or related field

Skills

• High energy level and strong organizational skills
• Creativity and latitude for problem solving
• Basic computer skills (Word and Excel)

Education

• High School or GED - Required