Supervisor, Microbiology

Fresenius Kabi•Wilson, NC

About The Position

The Supervisor, Microbiology reports to the Manager, Microbiology and leads staff ranging from lab technicians through Lead Scientist levels. The role is responsible for hiring, developing, coaching, counseling, managing, and motivating staff, and for ensuring timely and 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 validation or improvement opportunities and develops protocols; and keeps the manager informed of departmental activities and product-related events. The supervisor oversees daily laboratory operations, personnel training and development, testing and monitoring programs, investigations, equipment and supply readiness, and validation and qualification activities. The position works with Production, Quality Assurance, Chemistry, Maintenance, Metrology, and Validation to meet environmental monitoring, product testing, preventive maintenance, calibration, and requalification schedules. The supervisor may act as a Manager when the manager is absent and represents the department in cross-functional teams and meetings. The salary range is $73,614–$103,528. The position is eligible to participate in a bonus plan with a target of 6% of base salary. Final pay depends on factors including experience, education, knowledge, skills, and abilities. Employment is at-will and does not create a guaranteed or permanent employment arrangement.

Responsibilities

Supervise daily activities of scientists and technicians and ensure job deadlines are met.
Hire department personnel and oversee their training, morale, and development; conduct performance evaluations.
Ensure execution of monitoring and testing programs for raw materials, components, in-process and finished goods, environmental and utilities systems, and production-process effectiveness.
Establish goals for timely product release and project performance, monitor progress, and implement corrective actions as needed.
Generate or revise Standard Operating Procedures for microbiology test procedures.
Ensure out-of-specification or unexpected results are promptly investigated, identify potential sources and corrective actions, and evaluate product impact.
Prepare and analyze summary reports to identify significant adverse quality trends, including 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, and mentor new personnel using SOPs and training checklists.
Ensure the department has functional, calibrated equipment and necessary supplies.
Supervise investigations of nonconforming raw materials, products, or components and determine disposition.
Coordinate with Production, Quality Assurance, Chemistry, Maintenance, Metrology, and Validation to meet monitoring, testing, preventive maintenance, calibration, and requalification schedules.
Supervise qualification and requalification programs for production and laboratory personnel.
Investigate and resolve nonconforming test results through thorough Deviation, OOS/OOT, EE, and Investigation processes.
Ensure adequate evaluation of new product processes and supervise validation activities for the responsible area.
Act as a Manager in the manager's absence when needed.
Represent the department on cross-functional teams and in meetings.
Assume other duties and responsibilities as assigned.