Quality Assurance Inspector II

Education

• High School or GED - Required

• All Functions of QA Inspector I, Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures.
• Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab.
•  Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications.
• Maintaining detailed records of sampling, inspections and testing activities.
• Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA.
• Collection of packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures.
• Conduct in process testing per manufacturing and packaging batch record instructions.
• Prepare controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures.
• Maintenance of standard weights required to perform daily verification of balances.
• Labeling component receipt, visual examination, counting, preliminary inspection and sampling.
• Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards.
• Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room.
• Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork.
• Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.
• Plus the following:
  • Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)
  • Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
  • Verification of functionality of all the equipment and associated controls during the batch run
  • Maintenance of retention sample room and monitoring of temperature and humidity, replacement fo chart records as per schedule, review of log and disposition of samples.