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.
Come be a part of our team and our mission as a Quality Specialist!
Principal Job Duties and Responsibilities:
- Maintain Quality System data.
- Triage document number requests from Quality Web.
- Assist employees in obtaining identification numbering for controlled documentation.
- Enter training events into the BFDX database.
- Scan old and new records for maintenance and traceability.
- Verification of scanned documents on Quality Web.
- Verify unique identifiers for software discs, batch record discs and labels.
- Enter new employees into the training database
- Track read-only training for implementations.
- Work with departmental managers to set up required trainings for new employees
- Post documents to document database from the local network drive.
- Provide basic guidance on QMS processes.
- Triage document check-out requests for updates.
- Create controlled copies of software discs/USBs for requested software.
- Enter completed training forms into TrainingWeb software for implementation orders.
- Provide training records during external audits
- Post approved Quality Web documents to the internal database.
- Update departmental WIDs (work instruction documents)
- Assist in projects and meetings as directed by the Document Control Manager
- Process change orders/temporary change orders for implementation into the Quality system
- Train and mentor Quality Technicians on document control procedures
- Verify proper individuals are approving documentation.
- Identify process deficiencies in departmental WIDs and update as necessary
- Identify and escalate non-conformances observed during document processing
Training and Education
- High school diploma or equivalent is required
- Associates degree in life science or engineering discipline preferred.
- Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required
- Completion of Medical Device Manufacturing Certificate program (provided by BioFire after hire) is required. Equivalent certifications may be considered in lieu of this certification (e.g. Six Sigma Green Belt, ASQ CQT)
- Work experience in a laboratory or life science manufacturing setting that has a formal quality system is required.
- For External Candidates: Minimum 4 years’ experience where reviewing, assessing and monitoring process and product compliance to standards was a primary job function. Education may be considered in lieu of experience.
- For Internal BioFire Candidates: Mastery of Quality Technician III principle duties, responsibilities, and decisions or equivalent external job experience required; education may be considered in lieu of experience.
- Effective written and verbal communication skills
- Proficiency in MS Office tools, including Outlook, Word, and Excel
- General computer operation
- Attention to detail is fundamental to this position.
- Ability to accurately follow written and verbal instructions.
- Organization skills as needed to maintain paperwork and task schedule.
- Proficiency in internet navigation
- Ability to write standardized and clear instructions
- Ability to effectively train, mentor, and coach others
Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if required).