Sr. Manufacturing Cell Processing Associate
Union City, Georgia
Perform stem cell preparation, cell expansions, tissue culture and manipulation using aseptic techniques in a clean room environment (Class 1,000/ISO 6 and Class 10,000/ISO 7).● Utilize good processing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.● Ensure batch records (LIMS) are accurately reviewed and product disposition timelines met in timely fashion.● Represent department in cross-functional teams, projects, and GXP- related problem resolution.● Provide training and coaching of the manufacturing support team in proper safety practices, cGMPs, and troubleshooting.● Work with SMEs to update digital and paper batch records and procedures.● Maintain records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.● Critically think and resolve issues that can potentially impact product quality, producibility, or operational safety.● Team Collaboration with SMEs, Supply Chain, QC, QA, and Processing Engineers to set and met business goals.