Carol Autry
Experienced Regulatory Affairs and Quality Assurance Professional in Gene Therapy, Pharmaceutical and Medical Device Industries
- Role
- Sr Principal, Qa Site Compliance - Inspection Readiness Steward at Eli Lilly and Company
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Carol Autry
Regulatory Affairs and Quality Assurance professional with diverse experience in the pharmaceutical and medical device industries.
Experience
Sr Principal, Qa Site Compliance - Inspection Readiness Steward
Jul 2024 — Present · Durham, NC, US
Education
East Carolina University
Bachelor of Science (B.S.), Biology with concentration in Biotechnology
1997
Temple University
Master of Science (M.S.), Quality Assurance/Regulatory Affairs
2006
Skills
- Quality System
- Clinical Trials
- Ectd
- Process Improvement
- Technology Transfer
- Good Manufacturing Practices (Gmp)
- Regulatory Submissions
- Change Control
- Medical Devices
- Capa
- Electronic Common Technical Document (Ectd)
- Gmp
- Annual Reports
- Biopharmaceuticals
- Auditing
- 21 Cfr Part 11
- Biotechnology
- Standard Operating Procedure (Sop)
- Corrective and Preventive Action (Capa)
- Quality Assurance
- U.s. Food and Drug Administration (Fda)
- U.s. Title 21 Cfr Part 11 Regulation
- Regulatory Affairs
- Pharmaceutical Industry
- Sop
- Fda
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