Randy Elderkin Email & Phone Number
Global Head of Engineering and Technical Services @ Kincell Bio
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Randy Elderkin Location
- Durham, NC, US
Randy Elderkin Work
- 2023 -now Global Head of Engineering and Technical Services @
- 2022 -2023 Sr. Director of Engineering and Validation @
- 2021 -2022 Senior Director of Validation and Facilities, Head of Technical Services @
- 2021 -2021 Director of Validation and Facilities @
- 2020 -2021 Director of Validation @
- 2018 -2020 Director of Validation @
- 2017 -2018 Senior Validation Manager @
- 2010 -2017 Sr. Validation Manager @
- 2008 -2010 Manufacturing Development Process Leader @
- 2007 -2008 Validation Manager @
- 2006 -2007 Sr. Validation Engineer @
- 2005 -2006 Quality Assurance Manager @
- 2002 -2005 Manufacturing Supervisor @
- 2000 -2002 Equipment Qualification Coordinator @
- 1996 -2000 Process Validation Technician @ Mallinckrodt - Graham Laboratories
- 1992 -1996 Supervisor @ Graham Laboratories
- 1990 -1992 Bead Technician - Bead production technician @ Graham Laboratories
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
- FDA
- CAPA
- Validation
- 21 CFR Part 11
- GMP
- Change Control
- Quality System
- Sop
- Computer System Validation
- GxP
- Pharmaceutical Industry
- Technology Transfer
- GLP
- Quality Assurance
- Cleaning Validation
- Pharmaceutics
- Quality Auditing
- Software Documentation
- Manufacturing
- Regulatory Affairs
- GAMP
- LIMS
- Quality Control
- Regulatory Requirements
- Six Sigma
- Lean Manufacturing
- Equipment Qualification
- Regulatory Submissions
- Analytical Chemistry
- Quality Management
- HPLC
- Calibration
- Trackwise
- Standard Operating Procedure (SOP)
- 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 Global 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 FDA, CAPA, Validation, 21 CFR Part 11, GMP and more. Randy Elderkin has 4 emails and 1 mobile phone numbers on RocketReach.
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