Quality Assurance Inspector II - 2nd Shift

Role Summary

Quality Assurance Inspector II – 2nd Shift. Responsible for monitoring and ensuring compliance of incoming materials, packaging components, and finished products with established specifications throughout the manufacturing process, including labeling control and packaging operations.

Responsibilities

• Perform all functions of a QA Inspector I.
• Inspect, sample, and test all incoming raw materials, packaging components, and returned goods according to 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 ensure conformance to specifications.
• Maintain detailed records of all sampling, inspection, and testing activities.
• Assign and verify expiry and retest dates for GMP raw materials using COAs.
• Collect packaged product samples for annual stability studies.
• Perform room, equipment, and packaging line checks prior to each manufacturing stage, following procedures.
• Conduct in-process testing as per batch record instructions.
• Prepare finished product samples for QC lab testing and QA retains, with proper documentation.
• Maintain standard weights for daily balance verification.
• Receive, visually examine, count, preliminarily inspect, and sample labeling components.
• Prepare inspection reports for labeling components/outserts; quarantine and release labels; maintain logs and inventory.
• Issue labeling components/outserts per packaging orders and monitor the label room.
• Complete QA final labeled product inspection reports and final line clearance, including labeling and packaging reconciliation.
• Ensure warehouse compliance regarding isolation of various product statuses.
• Isolate rejected materials generated during batch processing and ensure accountability in batch records.
• Monitor facility and product environmental operating conditions.
• Review engineering records and online batch records for completeness and accuracy before next steps.
• Verify functionality of equipment and controls during the batch run.
• Maintain retention sample room and monitoring of conditions; manage chart records and sample disposition.

Qualifications

Education

• High School or GED - Required

Experience

• 2 years of experience in QA or related field

Skills

• Organizational skills ‚Äì Advanced
• Creativity and latitude ‚Äì Advanced
• Basic computer skills (Word and Excel) ‚Äì Intermediate

Specialized Knowledge

• Proficient in Production Line Clearance procedures
• Strong math skills and attention to detail
• Ability to record observations and identify opportunities for process improvement
• Solid understanding of GMP
• Knowledge of SOPs and their application in a regulated environment

Additional Requirements

• Disposal of rejected material and returned drug products per SOP
• Environmental monitoring as applicable
• Prepare reports for customer complaints