Quality Assurance Associate II Position Available In Suffolk, New York

Description Perform in-process quality checks—including weight, thickness, hardness, disintegration, and friability—according to instructions in the manufacturing batch record. Conduct pre-manufacturing inspections of rooms and equipment by following detailed written procedures. Carry out Acceptable Quality Limit (AQL) sampling and inspections as required. Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab, ensuring accurate documentation and timely delivery of results. Maintain standard weight records and perform daily balance verifications. Properly isolate and document any rejected materials generated during batch processing. Monitor environmental conditions affecting both facility and product quality. Review engineering documentation, including temperature/humidity logs, calibration and preventive maintenance (PM) records, pest control logs, and contractor activity reports. Evaluate online batch records for completeness, including signatures, entries, and reconciliation/yield accuracy before proceeding to the next processing step. Confirm the functionality of all equipment and control systems during batch runs. Conduct relevant testing and prepare reports in response to customer complaints. Identify and escalate any non-conformances or discrepancies to management as needed. Perform additional duties or participate in special projects as assigned by management. Skills Quality assurance, Gmp, capa, sap, document control, pharmaceutical manufacturing, change control, deviation, batch record, mdi, document management, hplc Top Skills Details Quality assurance, Batch Record Review Additional Skills & Qualifications A minimum of 2-3 years of experience in quality assurance within a GMP-compliant pharmaceutical manufacturing environment conducting batch record review from an office setting and not the production floor. Experience with internal OOS and OOT investigations bachelor’s degree preferred