QA Inspector I

InvaGen Pharmaceuticals, Inc. • Hauppauge, NY • 1d ago

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.[TABLE]Description:- The QA Inspector (Manufacturing) is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing in compliance with established specifications.Essential Functions:- Responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications- Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.- Perform room and equipment checks (where applicable) prior to each stage of manufacturing process as guided through written procedures.- Perform AQL, Blend sampling, In-process Sampling, and inspections as required.- Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.- Maintenance of standard weights and perform daily verification of balances which includes physically carrying ability of 100 kg (25 Kg x 4 No's) weights for multiple balances.- Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.- Monitor facility and product environmental operating conditions.- Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).- Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.- Verification of functionality of all the equipment and associated controls during the batch run.- Perform applicable testing and prepare reports for customer complaints.- Identify and report any non-conformances/discrepancies to management if applicable.- Other duties that management may assign from time to time.Education:- Associate degree diploma or equivalent (required); strong background in science preferred.Experience:- 2-3 years of pharmaceutical industry experience, particularly in manufacturing or packaging (preferred).Skills:- Proficient user of personal computer hardware and software applications such as Microsoft Office, SAP, and other business applications.- Strong knowledge of GMP, regulatory requirements (FDA), and pharmaceutical manufacturing processes.- Prior experience in RX and generic pharmaceutical manufacturing/packaging is a plus.- Effective interpersonal relationship skills and the ability to work in a team environment.- Proficiency in the English language to include usage, spelling, grammar, and punctuation.- Must have current Good Manufacturing Practices (cGMP) knowledge.- Must have strong attention-to-detail.- Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.- Must have strong organization and communication skills (written, verbal)- Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.About CiplaCipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has eme

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