Randy Elderkin Email & Phone Number
Head of Engineering and Technical Services @ Kincell Bio
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Randy Elderkin Location
- Durham, NC, US
Randy Elderkin Work
- Head of Engineering and Technical Services @ (July 2023 - Present)
- Sr. Director of Engineering and Validation @ Inceptor Bio (Kincell Bio) (May 2022 - July 2023)
- Senior Director of Validation and Facilities, Head of Technical Services @ (December 2021 - May 2022)
- Director of Validation and Facilities @ (July 2021 - December 2021)
- Director of Validation @ (December 2020 - July 2021)
- Director of Validation @ Cognate BioServices (October 2018 - November 2020)
- Senior Validation Manager @ (June 2017 - October 2018)
- Sr. Validation Manager @ (June 2010 - May 2017)
- Manufacturing Development Process Leader @ (December 2008 - July 2010)
- Validation Manager @ (June 2007 - June 2008)
- Sr. Validation Engineer @ (June 2006 - June 2007)
- Quality Assurance Manager @ (June 2005 - June 2006)
- Manufacturing Supervisor @ (January 2002 - June 2005)
- Equipment Qualification Coordinator @ (January 2000 - January 2002)
- Process Validation Technician @ Mallinckrodt - Graham Laboratories (January 1996 - January 2000)
- Supervisor @ Graham Laboratories (January 1992 - January 1996)
- Bead Technician - Bead production technician @ Graham Laboratories (January 1990 - January 1992)
Randy Elderkin 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
Randy Elderkin Skills
- 21 CFR Part 11
- Analytical Chemistry
- Analytical Skills
- Auditing
- Biotechnology
- CAPA
- Calibration
- Capital Projects
- Change Control
- Change Management
- Communication
- Computer System Validation
- Corrective and Preventive Action (CAPA)
- Data Management
- Engineering
- Equipment Qualification
- FDA
- Facility Management (FM)
- GAMP
- GLP
- GMP
- GxP
- HPLC
- Interpersonal Skills
- LIMS
- Leadership
- Lean Manufacturing
- Manufacturing
- Pharmaceutical Industry
- Pharmaceutics
- Quality Assurance
- Quality Auditing
- Quality Control
- Quality Management
- Quality System
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Requirements
- Regulatory Submissions
- SOP
- Six Sigma
- Software Documentation
- Software Testing
- Software as a Service (SaaS)
- Standard Operating Procedure (SOP)
- Technology Transfer
- Trackwise
- U.S. Food and Drug Administration (FDA)
- Validation
- Cleaning Validation
- Data Validation
- Corrective and Preventive Action Capa
- See 19+see Less
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Computer System
- u.s. Food and Drug Administration
- Standard Operating Procedure
- Corrective and Preventive Action
Randy Elderkin Summary
- Randy Elderkin, based in Durham, NC, US, is currently a Head of Engineering and Technical Services at Kincell Bio. Randy Elderkin brings experience from previous roles at Inceptor Bio (Kincell Bio) and Matica Biotechnology, Inc.. Randy Elderkin holds a 2002 - 2006 Bachelors in Computer Science/Management @ State University of New York at Cobleskill. With a robust skill set that includes 21 CFR Part 11, Analytical Chemistry, Analytical Skills, Auditing, Biotechnology and more. Randy Elderkin has 3 emails and 1 mobile phone numbers on RocketReach.
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