Katalyst Healthcares & Life Sciences
Job Location : South Plainfield,NJ, USA
Posted on : 2024-11-08T11:48:49Z
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.