Andrea Shuttleworth Wittke
Senior Specialist Quality Assurance Operatons Compliance
- Role
- Senior Specialist Quality Assurance Operations Compliance at Bristol Myers Squibb
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Andrea Shuttleworth Wittke
I am a Microbiologist with over 25 years experience in Consumer Healthcare/Pharmaceuticals with experience in Microbial Limits testing, Tests for Specified Organisms, Product Stability, Method Suitability, Product Preservation, cGMPs, Microbial Risk Assessments, Microbial Specifications and acceptance levels for USP-NF and Ph. Eur.I have extensive experience with Environmental Monitoring: USP water testing, Ambient Air Sampling, Compressed Air Sampling, Microbial Swabbing of GMP Equipment.Provided microbiological advice and technical support to various consumer healthcare categories including: pain management, smokers health, oral health and GI product development teams, commercial and regulatory teams, main production facilities and contractor sites. Coordinated and managed the progression of projects and laboratory work within GSK Consumer Healthcare and external contractors.
Experience
Senior Specialist Quality Assurance Operations Compliance
Oct 2021 — Present · Summit, NJ, US
Education
University of Wisconsin-Madison
Bachelor's degree, Bacteriology, Environmental Studies
1990 — 1994
Seton Hall University
Master's degree, Biology, General
1998 — 2002
Skills
- Ambient Air Sampling
- Cleaning Validation
- Clinical Trials
- R&D
- Method Development
- Pharmaceutical Industry
- Sop
- Fda
- Microbial Limits Testing
- Research and Development (R&D)
- Technology Transfer
- Standard Operating Procedure (Sop)
- Out of Specification Investigation
- Compressed Air Sampling
- Filtration
- Laboratory
- U.s. Food and Drug Administration (Fda)
- Aseptic Processing
- Environmental Monitoring
- Glp
- Usp
- Risk Assessment
- U.s. Pharmacopeia (Usp)
- Laboratory Skills
- Good Laboratory Practice (Glp)
- Aseptic Technique
- Microbial Swab Analysis
- Lims
- Validation
- Method Suitability
- Gram Staining
- Vaccines
- Regulatory Submissions
- Preservative Efficacy Testing/Antimicrobial Efficacy Testing
- Quality Control
- Gmp
- Microbiology
- Water Testing
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