Quality Assurance Specialist
Skills
- Knowledge of ISO standards, Good Laboratory Practices, clinical guidelines, and manufacturing protocols
- Expertise in FDA regulations and regulatory environment compliance
- Proficiency in Google Docs, Google Drive, and Gmail
- Audit and inspection skills
- Strong organizational and communication skills
Responsibilities
- Maintain approved protocol documentation and master schedule of GLP-regulated studies
- Perform pre-qualification inspections of testing facilities
- Provide periodic status reports on facility and study compliance
- Inspect and audit to verify data integrity and regulatory compliance
- Communicate QA inspection findings to management
- Review study protocols and final reports for compliance with regulations and SOPs
- Prepare Quality Assurance Statements for final reports
- Write and review Quality Assurance SOPs
- Review equipment, software, and computer-system validations
- Inspect critical vendors and maintain personnel training records
- Conduct GLP training for staff as needed
- Serve as point of contact during FDA inspections
Education
- Bachelor of Science degree in science, engineering, or quality-related discipline
Benefits
- Medical, dental, and vision insurance (PPO)
- Paid holidays
- Commuter benefits
- Meals provided
- Equity and 401(k) plan
- Parental leave
- Flexible time off
- Growth potential and advancement opportunities
Average salary estimate
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