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.

 

Specialist, Right to Operate (QA Liaison)

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Right to Operate Specialist is responsible for supporting the Clinical Laboratory in adhering to state, local and federal regulations as well as internal policies and procedures. The position applies regulatory knowledge in fulfilling their job responsibilities and collaborates cross functionally to support client requests and follow up during onsite audits.

The Right to Operate group is vital in maintaining Foundation Medicine's business-critical certifications from external institutions. Right to Operate works with Clinical Operations, Quality Assurance, Regulatory Affairs and others to ensure FMI can deliver its world-class care to cancer patients around the globe.

 

Key Responsibilities

  • Maintain lab operation staff training/personnel files.
  • Support Quality Assurance in the procurement of documentation and fulfillment of requests for external audits.
  • Follow company policies and applicable procedures.
  • Execute work with adherence to GCP requirements and applicable regulations, including, but not limited to, CLIA, CAP, MA state, NY state.
  • Act as a laboratory operations liaison to internal customers.
  • Review competency assessment forms and ensure competency assessments are completed on time; maintain, monitor and report on competency assessment KPI and metrics.
  • Assist with Non-Conformance Report generation, review and trending.
  • Partner with the Laboratory Operations Management team in creation and review of Quality documents.
  • Respond to audit findings and coordinate the completion of response plans.
  • Support the continuous improvement of laboratory processes.
  • Support the Quality Assurance Internal Audit Program.
  • Support laboratory operations CAPA program.
  • Support external and internal proficiency programs including report writing.
  • Maintain availability to work outside of a regularly scheduled shift.
  • Travel domestically up to 10% of the time.
  • Other projects as periodically assigned.

 

Qualifications

Basic Qualifications

  • Bachelor’s Degree in Biology, Chemistry, or other Life Science field
  • 4+ years of experience in the pharmaceutical, biotechnology, medical device or diagnostic industries
  • 3+ years of experience with GMP, GLP or GCP processes

Preferred Qualifications

  • Prior experience with supplier/vendor management
  • Experience with internal/external audit
  • Experience with process validation
  • Able to work well under pressure while maintaining a professional demeanor
  • Able to prioritize and thoroughly follow up on assigned tasks
  • Able to handle multiple tasks at once and work in a fast-paced environment
  • Able to adapt to changing procedures, policies and work environment
  • Detail-oriented, organized and able to shift priorities based upon business needs
  • Excellent communication skills to effectively collaborate cross functionally
  • Understanding of HIPAA and the importance of patient data privacy
  • Demonstrated integrity and a commitment to values held at FMI: 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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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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