Quality Assurance Specialist I - Katalyst Healthcares & Life Sciences : Job Details

Quality Assurance Specialist I

Katalyst Healthcares & Life Sciences

Job Location : South Plainfield,NJ, USA

Posted on : 2024-11-22T09:17:20Z

Job Description :
Responsibilities:
  • Provide QA support on the floor for production.
  • Ensure process control measures are in place and followed in product manufacturing.
  • Receipt and disposition of incoming apheresis material.
  • Oversee and authorize shipment of final product.
  • Verify and ensure timely issuance of production documents and labels.
  • Review batch-related documentation and ensure resolution of issues to release and ship product.
  • Gather and report metrics to measure performance.
  • Ensure all product-related Deviations are initiated, investigated and resolved.
  • Ensure that associated CAPAs are initiated and resolved, as needed.
  • Perform lot closure activities.
  • Ensure approval and timely delivery of final product.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Requirements:
  • BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
  • Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
  • BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
  • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards.
  • Preferred PHARMACEUTICAL industry experience.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • General knowledge of aseptic manufacturing processes.
  • Proficient in MS Word, Excel, Power Point and other applications.
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