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 Licensure & Accreditation Lead, LIS

  • United States
  • Full Time

About the Job

The Associate Licensure and Accreditation, LIS is responsible for coordinating with the Laboratory and Accreditation and the SDLC teams to ensure compliance with laboratory information system 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 LIS software development accreditation compliance activities to ensure adherence to accreditation and regulatory standards, including the College of American Pathologists, NYSDOH, CLIA, CA, and ISO 15189. This position builds and maintains collaboration with the IT team and provides suggestions to current practices for compliance. The Associate Licensure and Accreditation, LIS aids FMI Quality department in the building and creation of systems to ensure an efficient and effective workflow.

Key Responsibilities

  • Evaluate current processes and suggest improvements to improve efficiencies.
  • Collaborate with the Sr. Licensure and Accreditation Lead and Technology teams on software development ensuring compliance with all applicable laboratory requirements.
  • Ensure all documentation and processes are documented to ensure regulatory compliance with national and state accreditation bodies as well as the College of American Pathologists.
  • Work with Quality Team leaders to build applicable KPIs and dashboards.
  • Serve as the Veeva expert within the QA LabOps team.
  • Gain a working knowledge of current and future capabilities across laboratory applications.
  • With the Sr. Licensure and Accreditation Lead, collaborate with laboratory leadership, cross-functional leads and staff to ensure lab activities and support are integrated into planning for LIS activities and ensure minimal disruption of operations during LIS maintenance or changes.
  • Maintain an understanding of laboratory technology and its application to achieve clinical and business objectives.
  • Recommend improvements to the interface QA process to improve quality, reduce project cycle time, and reduce bugs discovered during all phases of the project.
  • Ensure inspection readiness through activities including but not limited to maintenance of personnel records, ongoing document preparation and submission for surveys, conducting mock accreditation audits, and tracking corrective action to resolution.
  • Coordinate all accreditation and licensure activities to ensure compliance with applicable regulatory agencies, including facilitating and participating on team evaluation visits to sites seeking initial or reaccreditation.
  • Develop education programs regarding compliance of laboratory regulatory requirements and provides education by utilizing various delivery methods.
  • Develops up-to-date knowledge regarding accreditation standards, revisions in accreditation standards, and regulatory standards and requirements as identified through internet, literature review, standard review and conference resources.
  • Coordinate IT delegation process including personnel record audits to ensure compliance with regulatory qualifications, maintaining and coordinating delegation documentation, and review of delegation submissions.
  • Ensure inspection readiness through activities including, but not limited to, maintenance of complete and accurate records, and appropriateness.
  • 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.
  • Ensure that all remedial competency and training is performed for non-complaint proficiency testing.
  • Maintain accurate test menu, proficiency testing events, and maintains the employee rosters for site.
  • Ensure timely gathering and submission of licensure and application materials.
  • Update regulatory and accreditation policies and procedures in accordance with regulatory requirements, including the notation of the checklist requirement.
  • 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 coordinates 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

  • Bachelors in software engineering or computer science discipline with 0-3+ years of prior experience with quality systems and/or SW quality for medical device or healthcare software development; OR,
  • Associates degree in computer science or related field with 5+ years of experience in clinical laboratory or biopharmaceutical / medical device industry

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, QC and device 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-Remote

 

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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