Manufacturing Associate I
CurrentUpstream follows the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Ensures all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP). Upstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and… Show more Upstream follows the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Ensures all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP). Upstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, aseptic techniques for cell culture feeding, expansion and counting. Performing operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures. Documenting each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution. Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR). Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities. Participate and be accountable for room 5S. Utilize and perform maintenance on equipment per applicable SOP. Show less
