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Quality Assurance Auditor

Full Time | Boston | Massachusetts | United States


The Quality Assurance Auditor leverages expertise in efficient, regulation-adherent processes, assessments, and process improvements to develop and implement internal quality audits and risk assessments. The QA Auditor leverages expertise with external standards to identify specific issues for evaluation in the audit process, collaborates with stakeholders across the business on in-house standards, and conducts in-house audits with support of the QA Department. Through this process and resulting recommendations, the QA Auditor elevates and maintains quality for all functions. This position requires 25% travel.

Key Responsibilities:

  • Perform periodic audits and inspections of Quality System activities, which may include, but is not limited to:
    • Clinical study work and records,
    • Study reports,
    • Laboratory method Standard Operating Procedures,
    • Product batch records; and,
    • Other quality records, processes, and activities.
  • Perform external supplier and vendor audits (international and domestic).
  • Prepare reports of audit and inspection observations.
  • Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.
  • Assist with external audits performed by regulatory/inspection agencies or surveys and clients such as pharmaceutical companies or referral laboratories.
  • Assist with the compilation of audit findings for management purposes.
  • Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring
  • Apply Corrective and Preventive Action (CAPA) system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
  • Maintain familiarity with laboratory operating and quality assurance/quality control procedures to effectively perform laboratory quality assurance functions.
  • Support, maintain and continually improve Quality System.
  • Other duties as assigned.


Basic Qualifications:

  • Bachelor’s Degree and 5+ years in Quality Assurance

Preferred Qualifications:

  • American Society for Quality QA Certification
  • Auditor Certification (i.e. ASQ-CQA Certified, or ISO Auditor, or IRCA Certified)
  • Ability to communicate clearly and concisely with all stakeholders
  • Experience or familiarity with companion diagnostics or clinical lab operations
  • Scientific background in molecular biology and/or Next Generation Sequencing
  • Experience with managing QA activities across multiple quality system requirements (e.g. operating under both FDA CFR Part 820 and CLIA/CAP)
  • Familiarity with GMP, 21 CFR Part 11, FDA GMP, MA & NYS regulations, CAP, and CLIA
  • History of process-oriented and flexible approach
  • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
  • Demonstrated ability to consistently meet or exceed project deadlines
  • Understanding of HIPAA and importance of privacy of patient data
  • Ability to work well under pressure while maintaining a professional demeanor
  • Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues

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Internal applicants, please use your FMI email address.

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