Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Sr QA Auditor

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job 

As a member of the quality team, the Senior QA Auditor 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, GLP/GMP, ISO, IVDD/IVDR , Software Development Lifecycle and FDA
regulated environments.

Key Responsibilities

• Plan and lead internal audits of Quality System and Good Lab and Manufacturing Practices, which may
include, but is not limited to:
• Manufacturing
• Design Control
• Purchasing & Supplier Control
• Software Development Lifecycle
• 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).
• Manage FMI’s Approved Supplier List.
• Prepare reports of audit and inspection observations.
• Discuss audit and inspection findings independently with Management Staff and assist in developing
appropriate corrective and preventative actions.
• Act as the 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.
• 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, relevant Laboratory operating and quality
assurance/quality control procedures to effectively perform GLP & GMP quality assurance functions.
• Support, maintain and lead continuous improvement to the Quality Management System.
• Other duties as assigned.

Qualifications

Basic Qualifications
• Bachelor’s Degree
• 5+ years experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry

Preferred Qualifications
• ASQ Quality Auditor certified or equivalent
• Scientific or Engineering background
• Understanding/working knowledge of ICH and Good Clinical Practice guidelines
• Experience with:

 Auditing (Clinical Study work)
• Vendor Management
• Managing GLP and/or GMP activities across multiple quality system requirements (e.g.
operating under FDA, ISO, CLIA and CAP)
• Experience or familiarity with Companion Diagnostics or Lab operations
• Demonstrated ability to stay process-oriented, and demonstrate good judgement and decisionmaking
• Demonstrated ability to manage multiple projects and work independently
• Demonstrated ability to identify quality issues and effectively interface with internal and external
teams
• Demonstrated ability to communicate clearly and concisely with all stakeholders
• Strong attention to detail and the ability to manage multiple priorities with aggressive timelines
• Strong written and verbal communication skills
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion

#Li-Hybrid

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

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.

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.

Apply Now

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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