Quality Assurance Inspector II - Night Shift

Amneal

4d•Onsite

About The Position

The Quality Assurance Inspector II role focuses on monitoring and ensuring compliance with established specifications throughout various stages of manufacturing and packaging. This includes inspecting incoming raw materials, packaging components, and returned goods, as well as overseeing all phases of drug manufacturing. The position is also responsible for the receipt, inspection, release, and control of labels and outserts, ensuring quality compliance before, during, and after each packaging run. The role involves detailed record-keeping, sample preparation for analysis, and performing various checks and tests to maintain product quality and regulatory adherence.

Requirements

High School or GED - Required
2 years + experience in QA or related field
Good basic math knowledge
Excellent attention to details
Records observations for improving processes

Responsibilities

Monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested for compliance with established specifications.
Monitor and ensure all phases of drug manufacturing are in compliance with established specifications.
Receive, inspect, release, and control labels and outserts.
Ensure quality compliance before, during, and after each packaging run.
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 and deliver them to the QC lab.
Inspect and test packaging components using various measuring devices to determine conformance to specifications.
Maintain detailed records of sampling, inspections, and testing activities.
Assign and verify expiry dates and retest dates for all GMP raw materials.
Collect packaged product samples for annual stability.
Perform room, equipment, and packaging line checks prior to each stage of manufacturing.
Conduct in-process testing per manufacturing and packaging batch record instructions.
Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains.
Maintain standard weights for daily verification of balances.
Perform labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
Prepare labeling components/outserts inspection reports; quarantine and release labels and maintain incoming components log and corresponding inventory cards.
Issue labeling components/outserts according to packaging order and monitor/audit the label room.
Fill out the QA final labeled product inspection report, final line clearance, including labeling and packaging reconciliation paperwork.
Ensure compliance of warehouse areas, including isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
Ensure proper isolation of rejected material and accountability in the batch record.
Monitor facility and product environmental operating conditions.
Review engineering records (temperature and humidity data, calibration and PM records, pest control records, contractor-related functions).
Review online batch records for completeness of signatures, entries, and reconciliation/yields.
Verify functionality of all equipment and associated controls during the batch run.
Maintain the retention sample room, monitor temperature and humidity, replace chart records, review logs, and disposition samples.
Dispose of rejected material and returned drug products as per SOP.
Perform environmental monitoring in accordance with established schedule.
Perform applicable testing and prepare reports for customer complaints.
Perform other duties as assigned by management.