Quality Assurance Inspector - 2nd Shift

Role Summary

Quality Assurance Inspector - 2nd Shift responsible for sampling, inspecting and testing incoming materials, packaging components and returned goods to ensure compliance with established specifications and proper labeling control throughout manufacturing and packaging.

Responsibilities

• Perform inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods per 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 ensure specification compliance.
• Maintain detailed records of all sampling, inspection, and testing activities.
• Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house COAs.
• Collect packaged product samples for annual stability studies.
• Conduct room, equipment, and packaging line checks before each manufacturing stage.
• Perform in-process testing as per manufacturing and packaging batch record instructions.
• Prepare finished product samples for QC lab and QA retains, following documentation protocols.
• Maintain standard weights for daily balance verification.
• Label component receipt: visual examination, counting, preliminary inspection, and sampling.
• Prepare inspection reports for labeling components/outserts; manage quarantine and release labels, and maintain logs and inventory cards.
• Issue labeling components/outserts per packaging orders; monitor and audit label room activities.
• Complete QA final labeled product inspection reports and final line clearance, including reconciliation paperwork.
• Ensure warehouse compliance: proper isolation of Quarantine, Released, In-Process, Finished, Packaged, Returned, and Rejected goods.
• Isolate and document rejected materials during batch processes, ensuring accountability in batch records.
• Monitor facility and product environmental operating conditions.

Qualifications

• Experience: 1 year in QA or related field
• Specialized Knowledge: Good basic math knowledge and excellent attention to details; records observations for improving processes.

Skills

• High energy level and organizational skills. - Advanced
• A certain degree of creativity and latitude is required. - Intermediate
• Basic computer skills (Word and Excel) - Intermediate

Education

• High School or GED - Required

Additional Requirements

• Operate, maintain and calibrate hardness tester, fibrillatory, weight variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records
• Collection of 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 report of all products for APR
• Other duties as assigned by management