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 Reagent QC Laboratory Manager!
This position oversees assigned shifts of the Reagent QC (RQC) group and the processing of IVD product.
This includes the day to day operational management of the following QC processes:
- Final QC of IVD panel pouches and components
- Other non-IVD QC processes as directed
Note: the management of non-IVD QC processes may shift between Instrument and Reagent QC Managers over time owing to the growth of the department and shifting needs. This is at the discretion of the Associate Director of Quality Control or higher position within the department. Flexibility and adaptability is necessary for success.
In addition to managing these processes, the Reagent QC Manager is responsible for coordination of the following activities including the initiation, scheduling, and follow-up:
- Consistent delivery of inventory/ WIP to work sites of processes managed
- Initial training and continuous education of RQC team members
- Initiation, investigation, and disposition of NCRs
- Coordination between all RQC shifts and supervisors
The RQC Manager is expected to work closely with other RQC Manager(s) and the IQC Manager to ensure consistent application of department-specific policies and to develop IQC and RQC staffing flexibility to best utilize personnel.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Work with RQC supervisors to standardize areas of operator variability and continuously improve the training program.
- Ensuring sufficient materials and resources are made available to meet demand. This includes: understanding demand including demand variation, calculating operational capacity and identifying operational bottlenecks, planning for surges in demand as well as downtime to best utilize resources.
- Oversee the workflow management of IVD qualification processes by managing teams of QC Technologists and Technicians each headed by a Supervisor. This includes; leading operations meetings to maximize coordination between shifts, and providing reports to upper QC management as requested.
- Responsible for employee management including hiring decisions, final training completion approval, performance evaluations, and corrective actions.
- Mentor QC supervisor and QC teams to ensure a high level of proficiency and development.
- Assist the Associate Director of Quality Control with review of staffing needs with insight into growth including panel transitions, scheduling changes, multiple shifts, and capacity increases.
- Assist the Associate Director with review and continuous improvement of efficiency and risks including driving down complexity and minimizing product wait times.
- Attend meetings and provide feedback regarding changes in QC procedures or processes managed. Attend and participate in meetings pertaining to RQC quality tracking and trending.
- Maintain relationships with applicable departments upstream & downstream to those processes managed. Attend inter-departmental meetings to coordinate workflows across departments, troubleshoot bottlenecks, and ensure a high level of quality.
- Provide support to project management on transfer of new procedures or existing procedure/process revisions including participation in the QC work center.
- Suggest and prioritize improvements to batch records relevant to internal QC processes.
- Order equipment and supplies both internally and externally.
- Personnel management: PTO approval, scheduling, management reviews, team building, employee development, conflict mitigation and resolution.
- Performs other duties as assigned.
- Travel may be required for training or conferences. Will be limited and primarily local.
- Schedule is expected to straddle multiple shifts. Contact time with supervised direct reports is required.
- 2-4 direct reports (QC Supervisors) plus managing QC Technologists and Technicians as described in job duties/ responsibilities above.
Training and Education
Bachelor’s degree with an emphasis in a biological, chemical, or engineering field is required.
The following are preferred, but not required:
- Six Sigma certification
- Experience in and an understanding of cGMP environments
- Operations management training/experience
A minimum of 2 years lead or supervisory experience is required. A minimum of 5 years applicable laboratory experience is required OR 5 years combined experience in applicable BioFire departments (e.g. QC, R&D, BioMath, Template Control).
Knowledge, Skills and Abilities
- Mathematical competence
- Detail-oriented mindset and practice
- Well-developed interpersonal skills including the ability to effectively provide verbal and written feedback and direction.
- Proficient skills using Microsoft Office Suite products including excel, word, outlook
- Written communication. Email and document drafting/revision
- Problem solving
- Effective and demonstrated leadership skills including the ability to delegate
- Must be able to lift 25 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.