Quality Assurance Inspector II -2nd Shift

Amneal•Piscataway Township, NJ

3d•$21 - $27•Onsite

About The Position

This role monitors and ensures that all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested to determine compliance with established specifications. The position also ensures all phases of drug manufacturing comply with specifications, and handles the receipt, inspection, release, and control of labels and outserts. The Quality Assurance Inspector II is responsible for ensuring quality compliance before, during, and after each packaging run. The role requires the ability to work a 2nd Shift schedule from 3pm to 11:30pm.

Requirements

All Functions of QA Inspector I
Ability to work 2nd Shift schedule: 3pm to 11:30pm

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 and deliver them to the QC lab.
Inspect and test packaging components using various measuring devices (scales, micrometers, height gauges) 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 using vendor and in-house COAs.
Collect packaged product samples for annual stability studies.
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 the QC lab and QA retains.
Maintain standard weights required 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 orders.
Regularly monitor and audit the label room.
Fill out the QA final labeled product inspection report and final line clearance, including labeling and packaging reconciliation paperwork.
Ensure compliance of the Warehouse area in terms of isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
Ensure proper isolation of rejected material generated during batch processes 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 actual reconciliation/yields prior to the initiation of the next processing step.
Verify the functionality of all equipment and associated controls during the batch run.
Maintain the retention sample room, monitor temperature and humidity, replace chart records as per schedule, review logs, and disposition samples.
Disposition of rejected material and returned drug products as per SOP.
Perform environmental monitoring in accordance with the established schedule.
Perform applicable testing and prepare reports for customer complaints.
Perform other duties as assigned by management.