BioFire Diagnostics, LLC. is looking for a Pouch Area Supervisor to join our growing team! The Pouch Area Supervisor will be responsible for the daily work in the designated manufacturing areas of the Reagent manufacturing group including oversight of the people, processes and product. This position is expected to supervise and provide support to the teams in their designated work areas who are performing the daily scheduled work including Technical Leads, Team Leads and Technicians. The area supervisor will be responsible for ensuring the daily production schedule is met and overseeing product movement thru the area. This position will also be responsible for supervising behavior and performance of team members to ensure matters relating to personnel are addressed and will work with the manufacturing manager to resolve issues or pursue corrective action as necessary. The area supervisor will interact with engineering, maintenance, QA and management teams to resolve product, process, and equipment issues that may delay processing of product in a timely manner.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Provide daily supervision of Reagent manufacturing pouch & array production team including: correcting behavior & performance issues in real time and escalating issues to manager as needed, participate in corrective action with manger regarding performance/behavior issues as needed, ensure teams are following processes in compliance with company policies and Quality System Regulations, provide technical support to team leads as needed, work with team to adapt to changes affecting daily production schedule to ensure available team resources can meet planned production, participate in interviewing and hiring process as required.
- May assist with timesheet & PTO reviews/approvals and attendance tracking.
- Provide on time delivery of products by executing production schedule, and by resolving process/product related issues using tools such as Temporary Deviations, rework procedures, NCR’s, etc.
- Responsible for working with engineering on quality investigations including problem identification, corrective actions, data review and analysis and timely completion of documentation.
- Responsible for assisting Technical leads & Team leads with technical issues such as training, organization workflow, and troubleshooting production issues.
- Responsible for overseeing all in-process testing in the pouch and array areas and ensuring the control plan is being followed as documented.
- Ensure that R&D orders are completed correctly by communicating and clarifying special instructions to the team as necessary.
- Work closely with Operations management to identify and implement improvements to manufacturing processes.
- May serve as technical expert and contribute to decisions regarding developmental and process improvement initiatives such as automation, workflow design, and 6S.
- Exhibit a high level of organization and tremendous attention to detail in order to successfully manage this group.
- Communicate effectively with managers, other supervisors, leads and technicians.
- Perform additional tasks as assigned by management.
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
Training and Education: High School diploma or equivalent. A Bachelor’s degree or higher is preferred, but not required.
Experience: Minimum of two years of experience in an FDA/ISO manufacturing environment with a minimum of one year of leadership experience. Preference given to BioFire Diagnostics employees with experience in FilmArray pouch manufacturing. Experience in industry and knowledge of GMP/QSR/ISO preferred. Knowledge of real time PCR is a plus.
Skills: Well-developed interpersonal communication and team leadership skills. Ability to address and resolve employee performance and behavioral issues in a professional manner. General computer literacy in database, spreadsheet, and word processing software. Basic math skills. Ability to write reports, manufacturing procedures, and training material. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to organize, lead and evaluate the work of other personnel. Ability to communicate clearly in both written and oral formats.
Physical Requirements: Perform duties while wearing a PAPR.