SUPERVISOR, MICROBIOLOGY

Fresenius Kabi USA•Wilson, NC

3d•$73,614 - $103,528

About The Position

The Supervisor, Microbiology reports to the Manager, Microbiology and is responsible for hiring, developing, coaching, counseling, managing, and motivating staff. The position supervises laboratory technicians through Lead Scientist levels and ensures timely, accurate testing of environmental monitoring and utilities, raw materials, in-process materials, and finished products. The supervisor ensures compliance with GMP, company specifications, USP, and EP; identifies areas for validation or improvement and develops protocols; and keeps the manager informed of departmental activities and product-related events. The role may act as Manager when the manager is absent and represents the department on cross-functional teams and in meetings.

Responsibilities

Supervise daily activities of scientists and technicians and ensure work deadlines are met.
Hire department personnel and oversee their training, morale, and development.
Conduct performance evaluations.
Ensure monitoring and testing programs assess the quality of raw materials, components, in-process and finished goods, environmental and utilities systems, and production processes.
Set goals for timely product release and project completion, monitor performance, and implement corrective action as needed.
Generate new or revised Standard Operating Procedures for microbiology test procedures.
Ensure out-of-specification or unexpected results are promptly investigated, identify possible sources and corrective actions, and evaluate product impact.
Identify adverse quality trends through summary reports and address test results, environmental and utilities microbial profiles, and customer complaints.
Review staff work for accuracy, completeness, and conformance to specifications.
Oversee personnel training in appropriate techniques and related topics; mentor and develop new personnel, including training in SOPs and use of training checklists.
Ensure the department has functional, calibrated equipment and necessary supplies.
Supervise investigations of non-conforming raw materials, products, or components and determine disposition.
Coordinate with Production, Quality Assurance, Chemistry, Maintenance, Metrology, and Validation to ensure environmental monitoring, product testing, preventive maintenance, calibration, and requalification schedules are met.
Supervise qualification and requalification programs for production and laboratory personnel.
Investigate and resolve non-conforming test results by completing Deviation, OOS/OOT, EE, and Investigation documentation.
Ensure adequate evaluation of new product processes.
Supervise validation activities for the responsible area.
Act as Manager in the manager's absence, as needed.
Represent the department in cross-functional teams and meetings.
Assume other duties and responsibilities as assigned.