Shannon Langley
- Role
- Sr Manager, Microbiology Chemistry at 博士伦
- Location
- Greenville, SC, US
- LinkedIn followers
- 500 followers
About Shannon Langley
QA Microbiology and Chemistry in-process, finished product, and raw material testing for…
Experience
Sr Manager, Microbiology Chemistry
Nov 2010 — Present
February 2016 - present: Sr. QA Microbiology/Chemistry Laboratory Manager November 2010 - February 2016: QA Microbiology Manager Responsible for all Quality Control testing of raw material, sterile components, in-process, and finished product required to support sterile products. Environmental Monitoring of aseptic operations and validation support. Manage staff across 24/7 business operations. Support and approval of investigations.
Skills
- Validation
- Microbiology
- Biopharmaceuticals
- Aseptic Technique
- Gmp
- 21 Cfr Part 11
- Verification and Validation (V&V)
- Auditing
- Corrective and Preventive Action (Capa)
- Regulatory Requirements
- V&V
- Environmental Monitoring
- Laboratory Information Management System (Lims)
- Change Control
- Technology Transfer
- U.s. Food and Drug Administration (Fda)
- Quality Auditing
- Pharmaceuticals
- Lims
- Cgmp
- Pharmaceutical Industry
- Iso 13485
- Compliance Audits
- U.s. Title 21 Cfr Part 11 Regulation
- Capa
- Aseptic Processing
- Quality Assurance
- Good Laboratory Practice (Glp)
- Fda
- Cleaning Validation
- Glp
- Compliance
- Laboratory
- Sterility Assurance
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