Myriam Capehart
Quality Control Manager @ Akron Bio | Master\'s in Biology
- Role
- Quality Control Manager at Akron Bio
- Location
- Sarasota, FL, US
- LinkedIn followers
- 500 followers
About Myriam Capehart
Spearheading quality control at Akron Bio, I leverage my Master\'s in Biology, focusing on…
Experience
Quality Control Manager
Jun 2021 — Present · FL, US
Oversee both QC Analytical and Microbiology Departments, reporting directly to the VP of Quality, fostering high standards and a cohesive team dynamic- Led the collaborative development and establishment of the cGMP Quality Control Laboratory, ensuring team involvement throughout the project lifecycle- Directed a broad spectrum of validation projects, including cGMP method validation, clean compressed air qualification, clean room qualifications for ISO8/ISO7 and ISO5 environments, EMPQ, water systems (WFI), and equipment cleaning processes.Designed and implemented comprehensive cGMP testing protocols, encompassing environmental monitoring, WFI water system monitoring, compressed air and gasses monitoring, and gowning qualification processes- Managed the strategic relocation and centralization of the QC department from sister company location to current location, enhancing operational efficiency and team integration- Led the transfer, development, and validation of analytical methods in compliance with USP and ICH guidelines, ensuring methodological accuracy and regulatory adherence.Spearheaded cGMP production projects from a QC standpoint, upholding stringent quality standards throughout the production lifecycle- Implemented stability programs and protocols for Cell Banks and final cGMP products, in addition to Research and Master Cell Bank (MCB) testing for cGMP applications- Initiated and developed a Raw Material Specification project to systematically define the lifecycle and testing protocols for raw materials in cGMP contexts- Managed the site’s contamination control strategy, regularly issued Quarterly Environmental Monitoring (EM) reports, and authored investigation memos to uphold environmental integrity and regulatory compliance.Mentored and developed the team, cultivating a culture of excellence and continuous professional growth.
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