Expertise: aseptic practices/processes, material transfer, environmental monitoring of classified areas, gowning (incl. behaviors in classified areas) etc. The QA Ops Aseptic Processes Senior Specialist is responsible for developing, implementing, and overseeing the sterility assurance practices to maintain compliance with regulatory requirements and industry standards. * Approve AQ and aseptic audits (9000002094), coaching during APS is required periodically with the responsibility to assess the overall process and people * Approve aseptic summary of media sim; Approve or co-approve with the SAM the QMS gap analysis impacting Sterility Assurance topic (e.g. facility design) * Perform coaching/mentoring of operational/, provide Sterility Aseptic training, develop the
more