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Quality Assurance Auditor II

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

As a member of the quality team, the Quality Auditor II, GCP works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and to support a diverse array of projects and initiatives. This position contributes to QA activities across multiple quality system requirements, such as CLIA/CAP, GCP, ISO and FDA regulated environments.

Key Responsibilities

  • Plan and Lead internal audits of Quality System and Good Clinical Practices, which may include, but is not limited to:
  • Manufacturing
  • Design Control
  • Purchasing & Supplier Control
  • Clinical study work and records,
  • Study reports,
  • Laboratory method Standard Operating Procedures,
  • Product batch records; and,
  • Other quality records, processes, and activities.

• Perform periodic audits of Good Clinical Practice activities which may include, but is not limited to, BioPharma and Clinical Operations procedures, processes, records, and reports.

  • Plan and Lead external supplier and vendor audits (international and domestic).

• Prepare reports of audit and inspection observations.

  • Prepare reports of audit and inspection observations.
  • Independently discuss audit and inspection findings with Management Staff and assist in developing appropriate corrective and preventative actions.
  • Front Room/Back Room subject matter expert for external audits performed by regulatory/inspection agencies.
  • Develop and manage the compilation of audit metrics for management purposes and
  • Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring
  • Demonstrate strong proficiency in the application of the 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 FDA, ISO, IVDR, BioPharma, Clinical Operations and relevant Laboratory operating and quality assurance/quality control procedures to effectively perform GCP quality assurance functions
  • Support, maintain and lead continuous improvement to the Quality Management System
  • Other duties as assigned.

• Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.

Qualifications

Basic Qualifications

• Bachelor’s Degree or equivalent

• 5+ years experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry. Bachelors degree.

Preferred Qualifications

• ASQ Quality Auditor certified

• Auditing Experience (Clinical Investigator Site / Vendor)

• Experience with Vendor Management

• Experience with managing GCP activities across multiple quality system requirements (e.g. operating under FDA, ISO, CLIA and CAP)

• Experience or familiarity with Companion Diagnostics or Clinical Lab operations

• Scientific background in molecular biology and/or NGS

• Understanding/working knowledge of ICH and GCP guidelines

• Ability to manage multiple projects and work independently

• Process-oriented, with the ability to demonstrate good judgment and decision-making

• Ability to identify quality issues and effectively interface with internal and external teams

• Strong attention to detail and the ability to manage multiple priorities with aggressive timelines

• Strong written and communication skills

• Ability to communicate clearly and concisely with all stakeholders

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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