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.

 

Associate Clinical QA

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

Summary

Foundation Medicine is leading a transformation in cancer care, where each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease.

The QA team at Foundation Medicine works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and support a diverse array of projects and initiatives. This is a unique opportunity to contribute to QA activities across multiple quality system requirements (CLIA/CAP, ISO and FDA regulated environments).

The Clinical QA I will support hosting external audits and be responsible for planning and facilitating audit activities. The role requires regulatory knowledge and the ability to deliver results on schedule in a fast-paced and dynamic environment. Candidates must be detail-oriented with excellent organizational skills, able to assess new challenges and prioritize accordingly.

Located in the heart of Cambridge, MA—the world’s preeminent biotechnology hub—Foundation Medicine offers competitive salaries, generous benefits and ample opportunities for professional growth. 

Primary Responsibilities and Essential Duties

  • Support hosting external audits performed by regulatory/inspections agencies, surveys and clients, such as pharmaceutical companies or referral laboratories.
  • Support audit/inspection readiness training and activities.
  •  Track and monitor audit commitment to ensure timely response.
  • Support the issuance audit observations/ recommendations.
  • Support the preparation of audit reports and inspection observations.
  • Support the compilation of audit findings and responses as metrics for management purposes.
  • Assist in the internal GCP activities, such as internal audits.
  • Travel domestically up to 10% of the time.
  • Support other QA duties as assigned.

Core Competencies

  • Communicates Effectively- Capable of interacting with other functional teams productively. Able to absorb feedback provided. Contributes to building functional working relationships in the team.
  • Optimize Process and Drive results- Delivers requested tasks on time. Task oriented. Developing ability to work effectively as part of a team.
  • Plans and Aligns- Day to day work is completed systematically and time is managed well. Plans for and uses resources efficiently. Cooperates and collaborates with others to achieve objectives.
  • Culture and Values- Learns from mistakes. Exhibits core value in every interaction.
  • Technical Expertise- Support and participate in audit activities. Maintains accurate audit records. Acquires knowledge of FMI product/business. Maintains familiarity with internal laboratory operating and quality assurance/quality control procedures to effectively perform function. Learning understanding of root cause analysis and corrective and preventative action. Creates and collaborates on project and change control deliverables with oversight in alignment with  FMI’s governing procedures.

Desired Skills

  • Experience or familiarity with Companion Diagnostics
  • Scientific background in molecular biology and/or NGS desired
  • Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
  • Knowledge of Microsoft Office applications (e.g. Word, Excel, Powerpoint).
  • Must be detail oriented and able to effectively communicate verbally and in writing.

Education and Experience

  • Bachelor’s Degree in a science or engineering discipline and experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials

 

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)

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.