Quality Assurance Specialist
3 weeks ago
Primary Responsibilities:
- Perform investigations per established procedures
- Support problem solving and troubleshooting as part of investigations
- Generate quality records as needed (CAPAs, CCs) to support process improvements
- Review laboratory records (test packets, logbooks, etc.) and ensure they have
acceptable Good Documentation Practices and are following procedures
- Update and draft standard operating procedures and work instructions
- Communicate effectively with all team members
Minimum Qualifications:
- Bachelor’s Degree in a scientific, engineering, or other technical discipline
- 4 years of experience in a quality assurance setting
- Direct experience in record review, investigations, and root cause analysis
- Good understanding and compliance with principles of Good Documentation Practices
- Strong organizational and time management skills
- Excellent attention to detail
- Strong analytical skills
- Succeed when working independently and as part of a team
- Demonstrated work ethic and accountability
Preferred Qualifications:
- Experience working within a quality system (e.g. Veeva)
- Thrive in a fast paced, growing, and dynamic work environment
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