Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.