Quality Assurance Inspector

Role Summary

The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) to determine compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing comply with established specifications, including receiving, inspecting, releasing and controlling labels and outserts to ensure quality before, during and after each packaging run.

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 (where required) and deliver them to the QC lab. Inspect and test packaging components using devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintain detailed records of sampling, inspections and testing activities. Assign and verify expiry date and retest date for GMP raw materials through vendor COA and in-house COA. Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks 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 retention, 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. Prepare 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 the 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.

Qualifications

• Experience: 1 year or more in QA or related field.
• Specialized Knowledge: Good basic math knowledge and excellent attention to detail; 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

Additional Requirements

• Operate, maintain and calibrate hardness tester, Friabilitor, 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.