- 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
- Bachelor's Degree in a scientific, engineering, or other technical discipline
- 4 years of experience in a quality assurance setting in biotechnology, medical device or pharmaceutical setting
- Strong understanding of 21 CFR parts 210 and 211
- 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
- Experience working within a quality system or QMS (e.g. Veeva)
- Thrive in a fast paced, growing, and dynamic work environment
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Quality Assurance Specialist - San Jose, United States - Medix™
Description
Medix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today.
Primary Responsibilities:
Minimum Qualifications:
Preferred Qualifications: