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Associate Licensure

3 months ago

Morrisville, United States Foundation Medicine Full time
Job Description

About the Job

The Associate Licensure and Accreditation is responsible for coordinating with the Laboratory and Accreditation to ensure compliance with laboratory requirements and ensuring timely review of all new and current policies and procedures. This position is responsible for assisting the Sr. Licensure and Accreditation Lead with meeting current and future business goals by evaluating current and future processes and documentation to ensure compliance with applicable regulations. This role assists with accreditation compliance activities to ensure adherence to accreditation and regulatory standards, including the College of American Pathologists, NYSDOH, CLIA, CA, and ISO 15189.

Key Responsibilities
  • Ensures that all documentation and processes are meet regulatory compliance with national. (ie The College of American Pathologists and ISO 15189) and state (ie New York Department of Health and California Department of Public Health
  • Develops educational programs to foster an understanding of laboratory regulations utilizing various delivery methods.
  • Coordinate laboratory walkthroughs and ensure documentation for walkthroughs is managed in accordance with laboratory requirements.
  • Ensure inspection readiness through activities including but not limited to maintenance of records, ongoing document preparation and submission for surveys, conducting mock accreditation audits, and tracking corrective action to resolution.
  • Develop/update regulatory and accreditation policies and procedures in accordance with regulatory requirements including the notation of the checklist requirement for all Quality documents within the Document Control system.
  • Ensures that all remedial competency and training is performed for laboratory personnel.
  • Maintain accurate test menu, proficiency testing and alternative assessment events, and the employee rosters for site.
  • Ensure timely gathering and submission of licensure and application materials.
  • Aid federal and state regulatory agencies to related queries regarding licensure and accreditation.
  • Is responsible for tracking, review, maintenance, and supplement tracking of licenses.
  • Assist in root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
  • May coordinate and manage off-site inspections and assist the on-site teams of inspectors.
  • May assist in special projects, including site implementations, and activities as required.
  • Travel periodically (up to 5%) of the time.
  • Other duties as required.
Qualifications:

Basic Qualifications:
  • Bachelor's degree and a minimum of 1 years related experience; or an advanced degree without experience; or equivalent work experience
Preferred Qualifications:
  • Advanced Degree in the Sciences, Engineering or Business or a related field
  • 3+ years of laboratory accreditation/regulatory (e.g., CAP, NYSDOH, CA, CLIA, CMS, ISO 15189) experience and a working knowledge of laboratory operations
  • 1+ years of experience in the clinical laboratory as a Medical Technologist
  • ASCP or MT(AMT) Certification
  • ASQ Certification
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Experience supporting a CLIA laboratory
  • Experience with next generation sequencing methodology
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Working knowledge of Next Generation Sequencing
  • Evidence of knowledge of molecular biology
  • Familiarity with the College of American Pathologists (CAP) accreditation, CMS regulations, California, and NY DOH licensure requirements and compliance standards and practices
  • Strong skills in troubleshooting and problem solving
  • Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
  • Understanding of HIPAA and the importance of patient data privacy
  • Commitment to FMI's values: passion, patients, innovation and collaboration

#LI-Hybrid

About Us

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.

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)