Job Description

Description:

QA Inspector II is responsible for ensuring compliance with GMP standards through inspection, sampling, testing, documentation, and review activities across raw materials, packaging components, manufacturing processes, and finished products. This role builds upon the responsibilities of QA Inspector I and includes the following key functions:

Essential Functions:

• 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 to the QC lab.
• Use measuring devices (e.g., scales, micrometers, height gauges) to verify conformance to specifications.
• Assign and verify expiry and retest dates using vendor and in-house Certificates of Analysis (COA).
• Maintain detailed records of all sampling, inspection, and testing activities.
• Conduct room, equipment, and packaging line checks prior to each manufacturing stage.
• Perform in-process testing per batch record instructions.
• Prepare finished product samples for QC testing and QA retains, ensuring proper documentation.
• Collect packaged product samples for annual stability studies.
• Maintain standard weights for daily balance verification.
• Label receipt, visual examination, counting, preliminary inspection, and sampling of components.
• Prepare inspection reports for labeling components and outserts.
• Quarantine and release labels; maintain incoming component logs and inventory cards.
• Issue labeling components/outserts per packaging orders.
• Monitor and audit label room activities.
• Isolate rejected materials during batch processing and ensure accountability in batch records.
• Monitor facility and product environmental conditions.
• Complete QA final labeled product inspection reports and final line clearance, including reconciliation paperwork.
• Ensure proper segregation of Quarantine, Released, In-Process, Finished, Packaged, Returned, and Rejected materials.
• Review engineering records including temperature/humidity logs, calibration and PM records, pest control documentation, and contractor activities.
• Review online batch records for completeness of signatures, entries, reconciliation, and yield prior to next processing step.
• Verify equipment functionality and control systems during batch runs.
• Maintain retention sample room: monitor temperature/humidity, replace chart records, review logs, and manage sample disposition.

Additional Responsibilities:

• Disposition of rejected material and returned drug products as per SOP
• Performs environmental monitoring in accordance with established schedule (where applicable)
• Perform applicable testing and prepare report for customer complaints
• Other duties that management may from time to time assign.