Randy Elderkin
- Role
- Senior Director of Engineering and Validation at Kincell Bio
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Randy Elderkin
Pharmaceutical Management Professional with over 25 years experience in the regulated…
Experience
Senior Director of Engineering and Validation
Jul 2023 — Present
Education
State University of New York at Cobleskill
Bachelors, Computer Science/Management
2002 — 2006
State University of New York at Cobleskill
Associate of Applied Sciences, Computer Science
2000 — 2003
Skills
- Technology Transfer
- Change Control
- Regulatory Submissions
- Quality Management
- Standard Operating Procedure (Sop)
- Quality Control
- Six Sigma
- Pharmaceutical Industry
- Fda
- Cleaning Validation
- Calibration
- Validation
- Manufacturing
- Sop
- Capa
- Analytical Chemistry
- Gmp
- Regulatory Requirements
- Computer System Validation
- Quality Assurance
- Regulatory Affairs
- Lims
- Quality Auditing
- Equipment Qualification
- Software Documentation
- Lean Manufacturing
- Glp
- Gamp
- Hplc
- Corrective and Preventive Action (Capa)
- Trackwise
- Gxp
- U.s. Food and Drug Administration (Fda)
- Pharmaceutics
- 21 Cfr Part 11
- Quality System
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