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Katalyst Healthcares and Life Sciences
US - NY - Rensselaer
October 16, 2024
Responsibilities: The role focuses on the execution of qualifying and commissioning new equipment from scratch within a facility, with a primary emphasis on fill-finish operations. The position requires a strong technical background in equipment qualification, IQ/OQ, and aseptic processing, as well...
Katalyst HealthCares and Life Sciences
US - NC - Matthews
October 18, 2024
Responsibilities: • • uthor and review high-quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings) and support client in responding to health authority questions within defined timelines. •...
Katalyst Healthcares and Life Sciences
US - US
November 12, 2024
Responsibilities: • Responsible for the manual inspection, labelling, and packaging of clinical and commercial products. • Perform finished product packaging as required to satisfy all customer, internal, clinical, and other demand. • Ensure finished product is packaged in accordance...
Katalyst Healthcares and Life Sciences
US - MI - Port Huron
May 25, 2024
Responsibilities: • • Validation Protocol Development: • Develop and review validation protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols, ensuring alignment with regulatory...
Katalyst Healthcares and Life Sciences
US - NJ - Somerville
November 15, 2024
Responsibilities: • Conducts timely sample intake, including receipt, proper identification, storage and return shipments as needed. • Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing),...