Quality Assurance Specialist

Found in: Appcast US C2 - 2 weeks ago


San Jose, United States Medix™ Full time

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:

  • 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 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


Preferred Qualifications:

  • 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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