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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.

 

Senior Quality Assurance Specialist

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

About the Job

The Senior Specialist, Quality Assurance Laboratory Operations leverages skill in efficient, regulation- adherent processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations, and systems. The Senior Specialist is responsible, in order of business priority, for inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and making recommendations to improve the quality of processes and products.

The Senior Specialist ensures continued compliance with CLIA, CAP,  ISO 15189,  ISO 13485, FDA, and other applicable regulations.

Key Responsibilities

  • Assist in all aspects of the full operation, implementation, and maintenance of the Quality Management System (QMS) to ensure continued compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA), College of American Pathologists (CAP), and the FDA.
  • Review and approve information to ensure it meets FMI standards and procedures and is clearly and appropriately justified as applicable, including but not limited to:
    • Non-Conformance reports;
    • Deviation Investigations;
    • Corrective Action Preventative Action reports;
    • Quality Control records;
    • Maintain availability to the wider FMI business to consult and provide guidance on Good Practice (GxP) quality guidelines and specific regulations, including but not limited to:
      • Clinical Laboratory Improvement Amendments of 1988 (CLIA);
      • College of American Pathologists accreditation standards;
      • Good Clinical Practice (GCP);
      • 21 CFR Part 11 compliance;
      • Food and Drug Administration and FDA Good Manufacturing Process;
      • State regulations including Massachusetts, North Carolina, California, and New York.
    • Trigger risk assessment process as required per established regulations or procedures and coordinate and lead analyses.
    • Provide departmental training as needed as part of Site New Employee Onboarding Training.
    • Actively communicate with the various areas and departments to identify areas of improvement.
    • Assist with implementation of new processes to streamline current business and system practices to regulatory compliance with key stakeholders and department leaders.
    • Create, review, and approve documents including Standard Operating Procedures, Quality Metrics Reports, Annual Product Reviews, and other documents, as needed.
    • Coordinate audit responses process as it pertains to laboratory findings.
    • Maintain organization and attention to detail in a fast-paced workflow environment.
    • Assist with internal and external audits as necessary.
    • Lead or support FDA, CAP, and other regulatory agency inspections for backroom support/document retrieval as needed.
    • Provide support and contribute to other QA activities as needed.
    • Participate in projects associated with Quality activities as needed.
    • Work and interact cross-functionally with a variety of teams to foster a solution-focused approach to opportunities.
    • Approve incoming materials.
    • Travel domestically up to 5% of the time.
    • Other duties as assigned.

Qualifications

Basic Qualifications

  • Highschool Diploma or GED equivalent and 9+ years of experience in the medical device, diagnostics, clinical laboratory, or biopharmaceutical industry; OR,
  • Associate’s Degree in science or related field and 4+ years of experience in the medical device, diagnostics, or clinical laboratory industry; OR,
  • Bachelor’s Degree in science or related field and 2+ years of experience in the medical device, diagnostics, or clinical laboratory industry

Preferred Qualifications

  • ASQ certification or ASCP/AMT Certification
  • Prior experience working in a QA environment
  • Working knowledge of applicable business systems including: Veeva, Maximo, LIMS, and       Smartsheet
  • Exposure to regulatory compliance knowledge including, ISO 15189, CLIA, CAP, NYS, state requirements, GxP, ISO 13485, and 21 CFR Part 11 Compliance
  • Ability to multitask within specified timelines
  • Ability to work well under pressure while maintaining a professional demeanor
  • Detail-oriented with excellent prioritization and organizational skills
  • Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with departments and colleagues
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

 

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.

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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)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.