Carolyn R.
Manager, Clinical Supply QA
- Role
- Manager at Incyte
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Carolyn R.
I am a Quality Assurance professional with expertise in Lean Six Sigma, project management, change control, and laboratory management in highly regulated industry. My strengths include streamlining processes, developing personnel, and problem solving. I have worked primarily in pharmaceuticals with some experience in OTC, NHP, API, and Biologics manufacturing.
Experience
Manager
Mar 2023 — Present · US
Partner with Investigational Material Supply Chain to ensure the Quality of the Clinical Supply.
Education
University of Delaware
BS, 1) Food Science 2) Ag. Business Mgmt Minors - Biology, Chemistry
1989 — 1993
Temple University
MS, Quality Assurance and Regulatory Affairs
2003 — 2007
Dulaney High School
High School Diploma
Villanova University
Master's Certificate, Six Sigma
2010 — 2011
Skills
- Change Control
- Six Sigma
- Gxp
- Chemistry
- Nir
- Chemstation
- Computer System Validation
- Spectroscopy
- Technology Transfer
- Cgmp
- Uv
- Lean Manufacturing
- Instrumentation
- Regulatory Affairs
- Titration
- 21 Cfr Part 11
- Usp
- Cleaning Validation
- Quality Systems
- Capa
- Analytical Techniques
- Pharmaceuticals
- Regulatory Requirements
- Documentation
- Uv-Vis
- Cross-Functional Team Leadership
- Lc-Ms
- Dissolution
- Ir
- Wet Chemistry
- Quality Assurance
- Analytical Chemistry
- Nmr
- Validation
- Trackwise
- Process Validation
- Gmp
- Process Development
- Hplc
- Qc
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