Quality Assurance Specialist

2 weeks ago


New Brunswick, United States Katalyst Healthcares & Life Sciences Full time
Job Description RESPONSIBILITIES: Define processes within ExM (External Manufacturing) Americas and CMOs to support stability programs for Client products - primarily for those managed by GPQ Stability group and secondarily for those managed by ExM Americas - (e.g. identification of batches for stability program, sample collection and shipment to storage facility, associated batch documentation, protocol management). Support the ExM-Americas team with preparation for site Quality Council, compile relevant metrics, slides and post meeting minutes. Perform role of ExM Americas Quality Systems Training champion who is responsible for, but not limited to, facilitating and conducting department training, processing training documentation, running/reviewing reports from LMS, and assisting in the review of curricula and training effectiveness. Deliver classroom training on quality systems and cGMPs. Prepare and update training materials, documents and assessments as needed. Utilize OPEX to continuously improve the Quality Systems. As needed, support self-inspection, corporate and Health Authority inspections of ExM-Americas, APQRs and MAFFs (Market Action Fact Finding). REQUIREMENTS: Knowledge of solid dosage forms, parenteral technology, biologics or combination products. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them. Proficiency with the use of global systems and applications (e.g. Trackwise, SAP). Good technical writing capabilities, verbal, written communication and presentation skills. Good time management and organizational skills. Excellent interpersonal skills. Capable of managing multiple priorities and work with initiative. Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring all cGMP and regulatory requirements are met. REQUIRED QUALIFICATION: Minimum B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Pharmacy or Biotechnology. A minimum of 5 years experience in pharmaceutical, biologics, biotech or related industry with relevant experience. Experience in a Quality Assurance or Quality Control function is required. Experience in the manufacture/packaging of drug substance and/or drug product or quality. J-18808-Ljbffr

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