Cliff Gentry
Lead Specialist, QA
- Role
- Lead Specialist, Qa at Bluebird Bio
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Cliff Gentry
Dedicated Quality Assurance Professional, Non-Conformance Investigator, Manufacturing…
Experience
Lead Specialist, Qa
Jan 2023 — Present · Somerville, MA, US
Provide QA expertise in support of analytical methods, validation protocols, critical reagents, SOP’s, laboratory/OOS investigations, risk assessments, reports, and lab exception management/deviations.• QA oversight of contract testing for in-process and stability samples, review and approval of stability protocols and reports.• QA approval of change control, ensuring appropriate impact assessments to assure compliance with bluebird bio and industry requirements.• Represent Quality on internal and external CMO/CLO cross functional teams for development, method transfer, and assay validation projects.• Support CMC and Tech Transfer teams.
Education
Colorado Technical University
M.S.
University of Redlands
B.S.
Skills
- 21 Cfr Part 11
- Process Improvement
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- Quality Control
- Gmp
- Lean Manufacturing
- Biotechnology
- Cross-Functional Team Leadership
- Quality Assurance
- Quality System
- Root Cause Analysis
- Change Control
- Capa
- Quality Auditing
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