BioFire Diagnostics, LLC. is looking for a Team Lead for our swing shift Finished Goods team! The Manufacturing Team Lead is responsible for organizing and leading the activities of a work team or an area in a participative management manufacturing work environment. Personally directs process and provides peer leadership for the initiation and completion of scheduled production tasks. Performs work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
*PLEASE NOTE: The schedule for this position beginning January 3, 2021 will be every other Wednesday + Thursday -Saturday 6:00 PM - 6:00 AM. The selected candidate will continue to work and train on her/his current shift until January 3rd.*
Principal Job Duties and Responsibilities:
1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Provide direction, leadership, and supervision to production teams of regulated products and sub-assemblies including medical devices.
3. Participate in strategic planning and resource management to assure optimum utilization of personnel and material resources in order to meet or exceed production, team, individual, and business objectives.
4. Sustain efforts in the area of responsibility and organization. Develop a thorough understanding of the assigned production areas in order to identify improvement opportunities.
5. Maintain records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
6. Act as a catalyst for positive change.
7. Accurately appraise strengths and weaknesses, provide constructive feedback, reinforce individual and team performance.
8. Provide or procure training to accomplish overall objectives.
9. Operate Production Equipment.
10. Maintain organization and cleanliness of assigned production area(s).
11. Responsible for ordering Kanban items and maintaining stocks of critical raw materials and sub-assemblies, including monitoring of expiration dates.
12. Perform additional tasks as assigned by management.
13. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
1. Every manufacturing area has a working lead that is responsible for ensuring quality work is being performed, including but not limited to: proper adherence to line clearances, adherence to written procedures (WIDs, BRs, & SOPs), completion of QSR documentation, and proper identification and segregation of conforming and non-conforming product
1. Responsible for supervising the daily activities of 1-10 manufacturing trainees or technicians.
2. This position will not have any direct reports.
QualificationsTraining and Education: Internal candidates must have demonstrated proficiency as a Manufacturing Tech I, II, or III based upon management approval. External candidates must have a good understanding of contamination prevention and experience performing manual manufacturing tasks and visual inspections. Experience with electronic documentation systems is preferred.
Experience: Must have minimum of one year of manufacturing experience at BioFire Diagnostics in the specified manufacturing area. Consideration will be given to applicants with less than one year of internal manufacturing experience if prior leadership experience in a regulated manufacturing environment can be shown. For external applicants, a minimum of 2 years in a lead or supervisor role in an FDA/ISO regulated manufacturing environment is required.
Skills: Must have good reading, writing, and oral communication and comprehension skills. Must have a high attention to detail. Must have good math skills. Must be able to lead a team in a positive, professional manner. Must be able to adequately identify and redirect operators’ performance and behavior if it is not compliant with BFDX standards
Physical Requirements: Be able to safely lift and maneuver up to 50 lbs. Must be able to perform duties while wear a PAPR