Quality Assurance Inspector - 12 hour Schedule - Night Shift

Role Summary

The Quality Assurance Inspector I supports quality by overseeing the sampling, inspection, and testing of incoming raw materials, packaging components, and returned goods to ensure they meet established specifications. This role also provides quality oversight across all phases of drug manufacturing and ensures labels and outserts are received, inspected, released, and controlled. It follows a 12-hour rotating shift from 6:00 PM to 6:30 AM.

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 them 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 via vendor COA and in-house COA. Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks prior to manufacturing following detailed procedures. Conduct in-process testing per batch record instructions. Prepare finished product samples for QC lab and QA retention following documentation procedures. Maintain standard weights for daily balance verification.
• Handle labeling components: receipt, visual examination, counting, preliminary inspection and sampling. Prepare labeling component reports; quarantine and release labels and maintain logs and inventory cards. Issue labeling components/outserts according to packaging orders and monitor the label room. Complete QA final labeled product inspection reports and related packaging reconciliation paperwork.
• Ensure compliance of the warehouse area across isolation statuses including 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 Responsibilities

• 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 following all precautions and procedures.
• Visual inspection and preparation of reports of all products for APR.
• Other duties as assigned by management.

Additional Requirements

• OSHA-compliant respirator fit test is required.

Qualifications

• Education: High School or GED – Required
• Experience: 1 year or more in QA or related field
• Skills: High energy level and organizational skills; creativity and latitude; basic computer skills (Word and Excel)
• Specialized Knowledge: Good math knowledge and attention to detail; ability to record observations for process improvement