Diana Greene

Experience

1. Director of Quality Assurance & Metrology

   August Bioservices, LLC

   May 2021 — Present · Nashville, TN, US

   Responsible for oversight of Quality Assurance including Product Quality, Systems, Compliance, and Vendor Management. Review and approval of batch records, CoAs, CoTs, stability protocols, technical reports, change controls, CAPAs, deviations, OOS/OOTs, and validation documents for the Manufacturing Facility, Product Testing, and Development groups. Point of contact for client interactions involving QA. Review and approval of Quality Agreements, batch records, CoAs, and packaging labels. Perform lot disposition and release activities. Review and approval of technology transfer plans and reports. Responsible for the supplier management process, and to audit vendors, service providers, and off-site storage locations. Oversee document management and cGMP document archiving. Oversee the cGMP training program and lead project to increase training compliance. Implementation of MasterControl modules, validation, and training. Provide new hire training for cGMPs and Quality Systems. Ensure implementation of the cGMP self inspection program and inspection readiness activities. Established a program for QA On-The-Floor to reduce review time for batch records and real time issue resolution. Responsible for oversight of the Metrology department, and implementation of BMRAM.

Education

• Clemson University

  M.S., Microbiology and Molecular Medicine

  1995 — 1998

• Salisbury State University

  B.S., Biology, Immunology

  1991 — 1994