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 Pay and Benefits The pay range for this position is $65000.00 – $73000.00/yr. benefits start day 1 and they are eligible for 2 weeks vacation, 56 hours sick and wellness add 2 days mental health days Workplace Type This is a fully onsite position in Central Islip,NY. Application Deadline This position is anticipated to close on Jul 3, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.