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.
• 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.
• Prepare reports of audit and inspection observations.
• Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.
• Bachelor’s Degree or equivalent
• 5+ years experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry. Bachelors degree.
• 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.
Internal applicants, please use your FMI email address.
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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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