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.

 

Quality Assurance Specialist

  • Kit Creek Road, Morrisville, North Carolina, United States
  • Full Time

About the Job

The 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 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.

Key Responsibilities

  • Work and interact cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.
  • Utilizing root cause analysis tools and assisting departments in the completion and investigation of nonconformances and CAPAs to ensure compliance with applicable regulations.
  • Review 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 (NCR);
    • Laboratory Incident Reports (INC);
    • Deviation Investigations;
    • Quality Records (Laboratory documents, Equipment Calibration); and
    • Reference Laboratory Quality review.
  • Review incoming materials.
  • Perform laboratory walkthroughs, collate findings, and share results with the internal audit team and departmental leadership.
  • Generate metrics at the required frequency to drive accountability and delivery of business objectives.
  • Trigger risk assessment process, as required per established regulations or procedures, by collaborating with senior QA colleagues and participating in the subsequent review and analyses.
  • Participate in the audit and inspection response process.
  • Participate in cross-functional team projects.
  • Support regulatory agencies and state inspections.
  • Demonstrate subject matter expertise in FMI policies and applicable procedures.
  • Identify opportunities for improvement and efficiency in collaboration with Senior Specialists.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Highschool Diploma or GED equivalent with 3+ years of Quality Assurance experience in a clinical laboratory OR,
  • Associate's degree in science or a related field

Preferred Qualifications

  • Clinical Laboratory Scientist ASCP, AMT, or eligible
  • Bachelor's Degree in Science or Engineering
  • Experience working in a regulated, GxP environment
  • Quality systems specific experience, including:
    • Materials receipt and inspection
    • Corrective & Preventative Action, Deviation, and Investigation experience
    • Knowledge of Root Cause analysis tools
  • Operations experience in Quality Assurance, Quality Control, and Manufacturing, including batch record review
  • ASQ certification or ASCP/AMT Certification
  • Working knowledge of applicable business systems including: MasterControl, Maximo, LIMS, Veeva, and Smartsheet
  • Familiarity with GMP, 21 CFR Part 11, FDA, MA & NYS regulations, CAP, and CLIA
  • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
  • Demonstrated ability to consistently meet or exceed project deadlines
  • Ability to work well under pressure while maintaining a professional demeanor
  • Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with remote departments and colleagues
  • Excellent attention to detail and multitasking skills
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to reflect FMI's values: Passion Patients, Innovation, and Collaboration

#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.

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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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