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 Supervisor!
The Quality Assurance department provides Quality support across various departments within BioFire. The department is organized into six distinct subunits, consisting of Calibration & Preventive Maintenance, Document Control, BioReagents Manufacturing, Instrument Manufacturing, Servicing, and Incoming Material QC.
This is a full-time, non-exempt (hourly) position. Quality Supervisor are entry-level managerial personnel.
The Quality Supervisor will assist Quality Management in the day-to-day management of Quality personnel to support the needs of the Quality Assurance Department. This position builds upon the Quality Specialist III position, and may be asked to perform those activities as a regular part of their job.
This position requires a high level of self-direction and the ability to motivate others. The Quality Supervisor will monitor and assign daily work and ensure that work is completed in compliance with applicable company procedures.
Timely and accurate work is expected. This position regularly interacts and collaborates with other departments within BioFire. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.
Principle Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Monitor and assign day-to-day activities of Quality Specialists and/or Technicians to meet the needs of Quality Assurance.
- Manage time and attendance for direct reports, including time off requests.
- Assist with team tasks as needed based on resource availability.
- Evaluate team specific procedures for improvement opportunities. Refer findings to management.
- Continually assess individual and collective team performance and regularly provide feedback to team members.
- Regularly communicate team performance to management
- Consult with management as staffing issues and problems arise
- Participate in hiring activities for prospective Quality Specialists and Technicians.
- Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
- Oversee training of new and existing Quality Specialists and Technicians.
- Generic supervisory duties, include: Delegate duties and assure understanding of same; measure and appraise performance against job duties, objectives and projects; provide motivating work environment and accurate feedback on performance.
- Assist with the development and implementation of Quality System policies, processes and procedures.
- Supervise quality testing and inspection, work in progress and finished goods.
- Supervise release of Finished Goods to stock.
- Develop and maintain performance metrics for instrument inspection activities for both new production builds.
- Assist Quality Technicians and Specialists to ensure that only conforming product is released for distribution in the field.
- Supervise scheduling and performance of manufacturing area sweeps to ensure audit/inspection readiness.
- Supervise NCR Management process: review NCRs to confirm all necessary activities have been done, are properly documented, and materials have been accurately physically and electronically dispositioned; close NCRs.
- Supervise TCO management process: ensure proper handling of TCOs, from review and approval to expiration or implementation of change order
- Prioritize and assign daily work tasks
- Evaluate acceptability of individual and team performance
- Ensure product and process compliance
- Evaluate and monitor staffing and resource needs
- Evaluate adequacy of prospective team members
- Pass/Fail determinations regarding instrument QA testing
- Quarantine and release product from quarantine
- Referral of non-routine and complex issues to higher authority and/or functional experts.
- Alert manager of nonconforming events.
Minimal domestic travel may be required for training purposes
- Work experience in a laboratory or life science manufacturing setting that has a formal quality system is required.
- Internal BioFire Candidates: Mastery of Quality Specialist III principle duties, responsibilities, and decisions or equivalent external job experience required; education may be considered in lieu of experience.
- For External Candidates: Minimum 6 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.
- Previous experience leading teams of people, preferred.
- 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 develop and write standardized and clear instructions
- Ability to effectively train, motivate, mentor, and coach direct reports
- Ability to identify and resolve problems
- Understanding of basic leadership and management principles (e.g. teamwork, conflict resolution, expectation setting, holding others accountable)
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.