Audra Reeve
@audrareeve
I lead sterility assurance investigations and contamination-control programs for aseptic pharmaceutical manufacturing.
United StatesWhat I'm looking for
At Eli Lilly, I lead root cause investigations, CAPA effectiveness evaluations, and global GMP document adoption for an aseptic pre-filled syringe filling line. I identified a previously unrecognized supplier-linked contamination pathway while investigating recurring foreign-material events.
I've also led quality control, R&D, and cell therapy process development teams at ALK, Rejoice International, and Lonza. My work spans aseptic processing, cleanroom practices, environmental monitoring, laboratory testing, technical writing, and mentoring colleagues in cGMP environments.
Experience
Work history, roles, and key accomplishments
Led root cause investigations into contamination events on an aseptic pre-filled syringe filling line and directed site-wide GMP procedural adoption assessments. Authored sterility impact assessments and coordinated CAPA effectiveness evaluations.
Manager, Research & Development
Rejoice International
Sep 2024 - Mar 2025 (6 months)
Optimized product formulations for performance, cost-efficiency, and regulatory compliance. Conducted stability testing, analyzed performance data, and prepared documentation for regulatory submissions.
Manager, Quality Control
ALK
Jan 2023 - Dec 2024 (1 year 11 months)
Oversaw QC administration, scheduling, budgeting, and technical services projects. Ensured cGMP compliance, managed product testing, and trained personnel on microbiological investigations.
QC Chemistry Supervisor, Quality Control
ALK
Jan 2022 - Dec 2023 (1 year 11 months)
Supervised QC analysts, distributed workload, and monitored progress. Reviewed test reports, ensured training and safety, and served as first-level SAP/IT support.
Supported development and execution of cGMP manufacturing processes for cell therapy. Performed cellular, biochemical, and molecular techniques and maintained detailed records following GDP.
Executed aseptic process manipulations for cell cultures and generated cGMP documentation. Served as certified trainer and used Lean principles to improve production effectiveness.
Education
Degrees, certifications, and relevant coursework
University of Texas at Austin
Bachelor of Science, Microbiology
Bachelor of Science in Microbiology from the University of Texas at Austin.
Availability
Location
United StatesAuthorized to work in
Salary expectations
Job categories
Skills
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