Shelley Wilson
Senior Specialist, Quality Assurance at Merck
- Role
- Senior Specialist, Quality Assurance at Merck
- Location
- New Hope, PA, US
- LinkedIn followers
- 500 followers
About Shelley Wilson
Possess a unique complement of skills in quality assurance and quality control at both pharmaceutical and medical device companies. Perform vital quality assurance roles such as approval of manufacturing batch records and final product release. ASQ Certified Quality Engineer (CQE). Well versed in auditing processes both internally and externally (FDA, DEA, and EU). Certified Quality Internal Auditor. Extensive experience during audits as: front room lead, back room lead, scribe and subject matter expert (SME). Experienced in compliance with FDA, CFR, cGMP, GLP, ISO 9001, ISO 13485, and ICH regulations. Managed a rapidly growing QC Analytical lab and set up new laboratories and processes.
Experience
Senior Specialist, Quality Assurance
Dec 2019 — Present · West Point, PA, US
Education
Wingate University
BS, Chemistry
2000
Skills
- Quality Auditing
- Lims
- Hplc
- Analytical Chemistry
- Change Control
- Quality Control
- Gmp
- Regulatory Affairs
- 21 Cfr Part 11
- U.s. Food and Drug Administration (Fda)
- Technology Transfer
- Medical Devices
- Capa
- Pharmaceutical Industry
- Fda
- Validation
- Quality Assurance
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