Overview
Quality Assurance Inspector II Jobs in Brookhaven, New York, USA at Amneal Pharmaceuticals LLC
Location: Brookhaven
Description:
To monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested (where applicable) for compliance with established specifications. To oversee all phases of drug manufacturing to ensure adherence to specifications. To receive, inspect, release, and control labels and outserts. To ensure quality compliance before, during, and after each packaging run.
Essential Functions:
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 packaging components using measuring devices like scales, micrometers, and height gauges to verify conformance. Maintain detailed records of sampling, inspection, and testing activities. Assign and verify expiry and retest dates for GMP raw materials based on vendor and in-house COAs.
Collect samples of packaged products for annual stability testing. Conduct room, equipment, and packaging line checks prior to each manufacturing stage. Perform in-process testing per batch records. Prepare samples for QC lab and QA retains, maintaining proper documentation. Maintain standard weights for daily balance verification. Label, visually examine, count, and sample components. Prepare inspection reports for labeling components/outserts, and manage quarantine and release procedures.
Issue labels and monitor label room activities. Complete final product inspection reports and line clearance documentation. Ensure proper segregation of quarantine, released, in-process, finished, returned, and rejected materials. Manage rejected materials and maintain accountability. Monitor environmental conditions of the facility and product areas.
Review engineering records such as temperature, humidity, calibration, PM, pest control, and contractor records. Review online batch records for completeness and accuracy before proceeding. Verify functionality of equipment during batch runs. Maintain and monitor the retention sample room, including temperature, humidity, and record keeping. Oversee labeling component receipt, visual inspection, and inventory management. Ensure compliance of warehouse areas with proper segregation of materials.
Confirm batch record accuracy and batch reconciliation.
Additional Responsibilities:
Disposal of rejected materials and returned products according to SOPs.
Conduct environmental monitoring as scheduled (where applicable).
Test and prepare reports for customer complaints.
Perform other duties as assigned by management.
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Title: Quality Assurance Inspector II
Company: Amneal Pharmaceuticals LLC
Location: Brookhaven, New York, USA
Category: Quality Assurance – QA/QC (Quality Technician/ Inspector, Quality Control / Manager, QA Specialist / Manager), Manufacturing / Production (QA Specialist / Manager)
