Quality Assurance Specialist

5 days ago


Cambridge, Cambridgeshire, United Kingdom ZipRecruiter Full time

**Job Overview:**

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for the life science sector. We are seeking a highly skilled Quality Assurance Specialist to join our team.

The ideal candidate will have experience in instrument or computer system validation, particularly in the biotech/pharmaceutical industry. A strong understanding of process automation, GAMP methodologies, and CFR Part 11 Electronic Records and Signatures requirements is essential.

Key Responsibilities:

  • Support the QC Analytical department in maintaining CGMP status of QC Instrumentation hardware and software.
  • Author CAPAs for systems with long-term remediation activities.
  • Develop and execute deliverables such as Risk Assessments, Validation Plans, Change Impact Assessments, and Summary Reports.

**Requirements:**

  • Minimum 2 years of experience in validation in a biotech/pharmaceutical environment.
  • Bachelor's Degree in Engineering, Life Science, or Computer Science.
  • Excellent working knowledge of process automation and computer system validation concepts.

**Estimated Salary:** $85,000 - $110,000 per year, depending on experience.

**Benefits:** Medical, dental, and vision healthcare benefits, as well as opportunities for professional growth and development.



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