Steve Drzick
Quality Assurance Specialist at Charles River Laboratories
- Role
- Quality Assurance Specialist at Charles River Laboratories
- Location
- Kalamazoo, MI, US
- LinkedIn followers
- 500 followers
About Steve Drzick
As a member of the Quality Assurance group, I interact with the Quality Assurance Department, Regulatory Affairs Department, Operations Departments, and Scientific Staff, as well as external Sponsors to assure GLP compliance. I joined the facility in August 2001 as a Research Associate, then was hired into the Quality Assurance Unit as an Auditor in August 2002. In August 2004 I became Project Coordinator, with responsibilities devoted to training as well as day-to-day Quality Assurance auditing tasks. After serving as a primary QA departmental trainer from May 2006 to December 2011, I switched roles and ultimately became a Quality Assurance Specialist. My current responsibilities include hosting Sponsor/Client audits and coordinating the staff discussions/interviews, document management, responses and corrective actions associated with the audits; performing GLP qualifications (surveys, site audits, questionnaires) of potential subcontracted test sites; curriculum development and coordination of corporate training sessions; performance of quarterly facility inspections; and providing compliance and trending information to Quality Assurance Unit management and Testing Facility Management.
Experience
Quality Assurance Specialist
Sep 2019 — Present · Mattawan, MI, US
Education
Arizona State University
None
1996 — 1996
Western Michigan University
Bachelor of Arts (BA), Applied Liberal Studies
1997 — 2001
Skills
- Hplc
- Software Documentation
- Curriculum Assessment
- Regulatory Affairs
- Lifesciences
- Validation
- Quality Assurance
- Classroom Management
- Metrology
- Sop Development
- Lims
- Epa
- Analytical Chemistry
- Histology
- Site Inspections
- Training
- Curriculum Innovation
- Public Speaking
- Business Process Mapping
- Computer System Validation
- Standard Operating Procedure (Sop)
- Regulatory Requirements
- Pharmaceutical Industry
- Sop
- Fda
- Gxp
- Quality Auditing
- Glp
- 21 Cfr Part 11
- Classroom Instruction
- Client Hosting
- Laboratory Skills
- Curriculum Development
- Biotechnology
- Laboratory Information Management System (Lims)
- Process Improvement
- Presentations
- Life Sciences
- Medical Devices
- Capa
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