Quality Assurance Specialist

3 weeks ago


San Jose, United States Medix™ Full time

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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