Formulation Team Lead - Night Shift (C Schedule)

Description

The Formulation Team Lead is responsible for maintaining the organization of the formulation labs.  This is a position of leadership and will require good communication with management as well as the ability to delegate responsibilities to others in the reagent formulation group.  The Lead is responsible for organizing and leading the activities of a work team or an area in a participative management manufacturing work environment.  The Lead personally directs projects and provides peer leadership for the initiation and completion of scheduled production tasks. 

Principal Job Duties and Responsibilities:

1. Perform all work in compliance with company policy and within the guidelines of its 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. Works within the quality system to troubleshoot failures. This includes performing investigations for NCRs as needed.
13. Perform additional tasks as assigned by management.
14. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).

Principal Decisions:

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.

Training, Education, and Experience:

Required: Minimum of a Bachelor’s degree in Life Science or Chemistry.  3+ years of work experience in FDA/ISO regulated industries considered in lieu of completed bachelor's degree.  A minimum of 1 year related experience at bioMerieux in the specified manufacturing area, or at least 2 years in a related field outside bioMerieux. cGMP experience is a must.

Desired:  Experience in laboratory manufacturing Industry and Knowledge of cGMP/QSR/ISO.  Experience in a leadership role.

Skills:

Must have good written and oral communication 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 bMx standards.

Physical Requirements:

Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).