Quality Assurance Inspector II - 2nd Shift

Amneal India•Piscataway, NJ

15h•Onsite

About The Position

The Quality Assurance Inspector II is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods comply with established specifications through sampling, inspection, and testing. This role also ensures that all phases of drug manufacturing adhere to established specifications. Additionally, the inspector is responsible for receiving, inspecting, releasing, and controlling labels and outserts, and ensuring quality compliance before, during, and after each packaging run.

Requirements

Ability to sample, inspect, and test incoming raw materials, packaging components, and returned goods.
Proficiency in preparing samples for analysis and delivering them to the QC lab.
Skill in inspecting and testing packaging components using measuring devices like scales, micrometers, and height gauges.
Capability to maintain detailed records of sampling, inspections, and testing.
Ability to assign and verify expiry dates and retest dates for GMP raw materials.
Experience in collecting packaged product samples for annual stability.
Ability to perform room, equipment, and packaging line checks.
Proficiency in conducting in-process testing per batch record instructions.
Skill in preparing samples for QC lab and QA retains.
Ability to maintain standard weights for balance verification.
Experience in labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
Proficiency in preparing labeling components/outserts inspection reports.
Ability to quarantine and release labels and maintain incoming components log and inventory cards.
Skill in issuing labeling components/outserts according to packaging orders.
Ability to monitor and audit the label room.
Proficiency in filling out QA final labeled product inspection reports and final line clearance paperwork.
Knowledge of warehouse area compliance, including isolation of different material statuses.
Ability to ensure proper isolation and accountability of rejected material.
Skill in monitoring facility and product environmental operating conditions.
Ability to review engineering records (temperature, humidity, calibration, PM, pest control).
Proficiency in reviewing online batch records for completeness and reconciliation.
Ability to verify equipment functionality during batch runs.
Skill in maintaining the retention sample room, monitoring conditions, and managing records.
Ability to dispose of rejected material and returned drug products.
Experience in performing environmental monitoring.
Capability to perform applicable testing and prepare reports for customer complaints.

Nice To Haves

Experience with Amneal's specific SOPs and procedures.

Responsibilities

Perform inspection, sampling, and testing of 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 visual examination, counting, preliminary inspection, and sampling of labeling components upon receipt.
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 the label room.
Complete the QA final labeled product inspection report and 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 and accountability of rejected material generated during batch processes.
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 before the next processing step.
Verify the functionality of all equipment and associated controls during batch runs.
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 the established schedule.
Perform applicable testing and prepare reports for customer complaints.
Perform other duties as assigned by management.