Description

Supervises daily work of the Technicians and Technologists in the Reagent QC group. This includes oversight of the employees, processes, and product while providing support to their team. Ensures daily and weekly tasks are completed including decontamination and housekeeping, participation in the swabbing program, and overseeing the processing of IVD product. Supervises performance of team members to ensure personnel matters are addressed and works with the Manager to resolve issues or pursue corrective action as necessary. Interacts with QA, BioMath, Manufacturing, Incoming QC, Engineering, Transfer Support, IQC, Software, Facilities, and other applicable departments to resolve product, process, and equipment issues. Creates and maintains a daily schedule of work performed by individuals to help manage capacity effectively and ensure rotation of job tasks. Ensures safety of Technicians and Technologists working in a laboratory environment.

Essential Job Duties and Responsibilities

• Perform all work in compliance with company policy and within the guidelines of the Companys Quality System.
• Provide daily supervision of Quality Control team including: correcting behavior & performance issues in real time and escalating issues to Manager as needed, participating in corrective action with the Manager regarding performance/behavior issues as needed.
• Participate in interviewing and hiring process as directed by the Manager.
• Timesheet & PTO reviews/approvals and attendance tracking.
• Ensure teams are following processes in compliance with company policies and Quality System Regulations.
• Provide technical support to QC Technicians and Technologists as needed.
• Work with QC employees and managers to continuously improve procedures.
• Execute training for changes to procedures.
• Coordinate with other supervisors and managers to ensure inventory levels are maintained accurately.
• Acts as the point of contact for questions and problems that Technicians and Technologists are unable to address. Ensure a timely response to department inquiries and quick resolution of problems.
• Provide high quality results by working with other supervisors and managers to track and trend common error modes within QC and recommend corrective actions.
• Responsible for working on quality investigations including problem identification, corrective actions, data review and analysis and timely completion of documentation.
• Responsible for assisting QC Technicians and Technologists with technical issues such as training, organization workflow, and troubleshooting issues.
• Work closely with Operations management to identify and implement improvements to processes.
• May serve as technical expert and contribute to decisions regarding developmental and process improvement initiatives such as addition of software tools, workflow design, standard work, and removing waste.
• Responsible for the coordination of new employee training and assess effectiveness of training.
• Work closely with the Health and Safety team to ensure a safe working environment for Technologists. This includes handling of biohazardous waste, proper use of a biosafety cabinet, spill clean-up, injury response and reporting, proper evacuation methods.
• 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 technologists.
• Perform additional tasks as assigned by management.

Supplemental Data

• Must work assigned shift but be available to stay late/ come in early occasionally for meetings to coordinate with other shifts.
• Must work mandatory overtime as assigned.
• Expected to be located primarily in the QC laboratory for the duration of the shift to be available to Technologists as needed. Limited participation in external meetings.
• 6-14 direct reports

Training and Education

• Associate Degree or Bachelor of Science in Life Science related field.

Experience:

• Management experience: 1 year of supervisory/ lead experience preferably at a life science organization OR 3 years of bioMerieux QC experience
• Laboratory experience: 5 years of applicable laboratory experience OR 3 years of combined experience in applicable bioMerieux departments (e.g. QC, BioReagents, R&D)

• Preference given to bioMerieux employees with experience in Quality Control and/or extensive experience with bioMerieux pouch/ component qualification.
• Experience in and understanding of cGMP environment is preferred

Knowledge, Skills and Abilities

• Well-developed interpersonal communication and team leadership skills, including demonstrated ability to provide written and verbal direction and feedback effectively.
• Detail-focus in mindset and practice
• 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, 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.
• Knowledge of PCR.

Physical Requirements

• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 25 pounds in all directions.