Come be a part of our team and our mission
At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.BioFire Diagnostics, LLC. is looking for a
Customer Clinical Compliance Specialist to join our team based in Salt Lake City, UT! The Customer Clinical Compliance Specialist will assist BioFire customers in ensuring they are in compliance with clinical laboratory regulations and accrediting agencies (e.g. CAP, CLIA, other agencies which may regulate clinical lab testing, etc.) with regards to BioFire Products. They will assist the customer in understanding matters related to the verification or validation of BioFire products within their laboratory. They will ensure the customer has all relevant information to allow them to identify compliance gaps and make necessary process improvements. They will assist the customer in understanding any inspection findings or deficiencies and make suggestions on process changes to bring the customer into compliance.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Provide technical expertise and guidance to BioFire customers relating to clinical laboratory compliance and accreditation matters.
- Respond to BioFire Diagnostics customers with questions regarding verification and/ or IQCP, and provide guidance on BioFire best practices.
- Collaborates with customers and applicable clinical laboratory regulatory authorities to develop positive and proactive approaches as it pertains to compliance and inspection readiness
- Recommends strategies for ensuring compliance to changes of applicable clinical laboratory regulatory standards
- Keep current with all internal procedures, as well as changes in all relevant clinical laboratory regulatory guidelines and subsequent standards
- Tracks BioFire customer regulatory inspection findings, and other similar complaints, and identifies trends
- Documents and properly trends all customer interaction with BioFire’s CRM
- Attend regular internal meetings regarding customer regulatory compliance, or other meetings as needed
- Participates in the development and documentation of BioFire recommended verification procedures.
- Reviews, creates, and updates documentation regarding the use and implementation of current and new products which may include manuals, instruction for use, manufacturer instructions, and/or quick guides.
- Strategize with customers on response to lab inspection findings as they pertain to BioFire products and/or recommendations
- Responds to customer requests in a timely manner
- As needed, respond promptly and accurately to calls or e-mails for product applications support or technical issues. Application support may involve help with product verification, product updates, training on product instructions for use (IFU), explanation of results interpretations and other technical inquiries.
- As needed, responsible for initiating, managing and resolving customer complaints. Will also determine if a complaint qualifies for FDA Medical Device Reporting (MDR) or EU Vigilance Reporting as well as determining if a complaint needs to be escalated for further investigation requiring the expertise of other departments.
- As needed, facilitate product returns through the RMA process.
- Up to 40% domestic travel may be required
- Some after-hours or on-call work may be required
Training and Education
- Bachelor’s degree in biological science or related area is required.
- Master’s degree in a biological science or related field is preferred but not required.
- ASCP certification preferred but not required.
- 5+ years’ experience in a laboratory compliance role within a CAP-accredited and CLIA certified laboratory setting.
- Previous experience creating verification and validation protocols including IQCP, managing inspections from regulatory bodies.
- Previous experience managing inspections from regulatory bodies and responding to findings.
Knowledge, Skills, and Abilities
- Excellent communication skills, both written and verbal.
- Must be able to interact with people of all scientific levels, such as clinical laboratory technicians, safety officers, managers, supervisors and directors; Ph.D. scientists; associate professors; key opinion leaders (KOL); clinical product managers; researchers; hospital administrators; medical engineers; and physicians.
- Ability to effectively write and/or create appropriate policies and procedures for implementation of BioFire products.
- Demonstrates knowledge of regulatory and accreditation requirements including, but not limited to, CLIA, CMS, COLA, CAP, and TJC.
- Knowledge of laboratory requirements pertaining to specimen collection, quality control (QC), individualized quality control plans (IQCP’s), proficiency testing (PT), test system validation/verification, quality assessment (QA), and training and competency assessment.
- Ability to communicate in one or more language(s) other than English is preferred, but not required.
Ability to lift and maneuver up to 40 lbs safely.
This position is based in Salt Lake City, UT and is not a remote.