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.
ABOUT THE JOB
The Quality Assurance Specialist leverages expertise 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.
Perform the Quality Assurance review and approval of Batch Records for the release of patient reports.
Review and approve select information to ensure it meets FMI standards and procedures and is clearly and appropriately justified as applicable, including:
Corrective Action Preventative Action reports;
Quality Control records;
Review and approve incoming materials.
Complete the quality control auditing of testing data.
Generate metrics at required frequency to drive accountability and delivery of targets.
Trigger risk assessment process as required per established regulations or procedures by liaising with senior QA colleagues and otherwise participating in these analyses.
Participate in the audit response process.
Become a subject matter expert in company policies and applicable procedures.
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:
Food and Drug Administration and FDA Good Manufacturing Process;
Massachusetts state regulations; and,
New York state regulations.
Other duties as assigned.
High School Diploma or General Education Degree and 4+ years of QA experience, OR Bachelor’s Degree and 2+ years of QA experience.
Bachelor's Degree in Science or Engineering.
5+ years of QA experience.
Experience working in a regulated, GxP environment.
Excellent attention to detail and multitasking skills.
Quality systems specific experience, including:
Materials receipt and inspection.
Corrective Action Preventative Action.
Root Cause analysis tools.
Review and approval of Quality Control test data.
Operations experience in Quality Assurance, Quality Control, and Manufacturing including batch record review.
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues.
Familiarity with GMP, 21 CFR Part 11, FDA GMP, 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.
Understanding of HIPAA and importance of privacy of patient data.
Ability to work well under pressure while maintaining a professional demeanor.
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)