Shirley Hamlette
QA Director at Kobo Products, Inc.
- Role
- Director of Quality Assurance at Kobo Products, Inc.
- Location
- Plainfield, NJ, US
- LinkedIn followers
- 500 followers
About Shirley Hamlette
Accomplished manager with 18 years of diversified R&D and manufacturing experience for a major pharmaceutical company. Successfully rose from packaging supervisor through quality and production supervisory positions to become Good Manufacturing Practices Training Compliance Manager. Ability to build solid internal and external customer relations while monitoring compliance. Skilled trainer and effective meeting and project manager who enjoys international travel.Specialties: GMP ComplianceBatch Record ReviewGMP Training
Experience
Director of Quality Assurance
Jan 2015 — Present
Education
Norfolk State University
B.S., Biology/Chem
Skills
- Word
- Outlook
- Gamp
- Trackwise
- Pharmaceutics
- Capa
- Production
- Manufacturing
- Auditing
- Fda Gmp
- Lims
- Cleaning Validation
- Change Management
- Cgmp
- Project Management
- Change Control
- Excel
- Technology Transfer
- Process Improvement
- Project Planning
- Pharmaceuticals
- Regulatory Requirements
- Quality System
- Document Management
- Iso 13485
- 21 Cfr Part 11
- Quality Assurance
- Regulatory Affairs
- Computer System Validation
- Quality Control
- Gmp
- Problem Solving
- Operations Management
- Microsoft Word
- Quality Management
- Compliance
- Microsoft Office
- Packaging
- Training
- R&D
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