Job Description
The QA Specialist performs and manages the facilitation of compliance reviews and audits of internal systems, processes, clinical trial data, and functional areas as per department standard operating procedures, good clinical practices, Federal and State regulations.
Job Requirements
Education:
- High School diploma or GED required.
Experience:
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Minimum 2 years QA experience in clinical research industry, GCP-focused, and GLP preferred.
- In-depth knowledge of U.S. Federal Regulations and Guidelines as well as international standards and guidelines for clinical trial conduct.
- Familiarity and experience with validation requirements and Part 11 preferred.
Job: Quality / Risk Management
Organization: Rockwood Clinic
Employee Status: Full-time
Shift: Day Shift
Country: USA, State: Washington, City: Spokane, Company: Rockwood Clinic.
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