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Company Contact Info
5 Ramsey Road
Shirley, NY 11967
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QA Inspector, 3:30pm-12am
American Regent, Inc • Shirley, NY
Posted 27 days ago
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American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectable pharmaceutical drugs for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
Nature and Scope
Adheres to proper cGMP’s including good housekeeping, proper protection of product quality and integrity, and personal hygiene. Read and understand written instructions and SOPs. Know and understand quality-related SOP requirements that determine appropriate process for conducting job performance.
Essential Duties and Responsibilities
- All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134) Drug product inspection.
- Checks product lot number information, documents in the batch record where applicable and reviews Master Batch Records for accuracy at all stages in the manufacturing process. Formulation, Filling Inspection and Packaging.
- Conducts product in-process inspections at designated intervals.
- Determines the Acceptable Quality Limits (AQL) by using the (American Nation Standards Institute) ANSI Z1.4 Standard Inspectors Rule, the ruler assists with the calculation of sample size and Accept/Reject. (A/R) numbers.
- Conducts inspection of formulation equipment (e.g. tanks).
- Documents verification of task performed (where applicable).
- Conducts in process weight checks of product filled in vials and ampoules.
- Conducts visual inspection of filled vials and ampoules after manual or automated inspection; for defined critical major and minor defects as well as particulate matter.
- Conducts inspection of printed materials (e.g. labels), inserts, finished units, unit packs and shipping containers for critical major and minor defects.
- Reports all non-conformances to supervision
- Perform any other tasks/duties as assigned by management.
Qualifications and Requirements
- High School or GED diploma required.
- Ability to read, write and communicate effectively, with the ability to work in fast-paced manufacturing environment.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.