Quality Assurance Auditor II at Foundation Medicine, Inc. in Cambridge, Massachusetts
Posted in General Business 30+ days ago.
Type: Full-Time
Job Description:
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.
- Plan and Lead external supplier and vendor audits (international and domestic).
- 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.
Qualifications
Basic Qualifications
Preferred Qualifications
Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
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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