Senior Microbiology Lab Supervisor GMP/QA Leader

Fresenius Kabi USA; North Carolina; Sur place; USD 74 000 - 104 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Résumé du poste

Fresenius Kabi USA is seeking a Supervisor in Microbiology to lead lab staff, ensure GMP and USP/EP compliance, and drive timely testing across environmental monitoring, materials, and finished products.

The role includes coaching, performance evaluations, SOP development, cross-functional collaboration, and mentoring new staff while maintaining calibrated equipment and testing programs.

Responsabilités

• Supervises daily activities of scientists and technicians.
• Assures that job activity deadlines are met on a timely basis.
• Hires and oversees the training of department personnel.
• Assures that steps are taken to maintain positive personnel morale and development.
• Conducts performance evaluations.
• Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
• Establishes goals for the timely release of product and performance of projects.
• Monitors performance of the group against the goals to identify and implement needed corrective action.
• Generates new/revise Standard Operating Procedures for Microbiology test procedures.
• Ensures that raw material, component, product, or monitoring results that do not meet specifications or expectations are promptly investigated.
• Identifies possible source and corrective action needed and evaluates the impact upon the product.
• Identifies significant adverse quality trends by preparing and analyzing summary reports.
• Addresses quality control test results, microbial profiles of environmental/utilities systems, and customer complaints.
• Reviews work performed by department staff for accuracy, completeness and conformance to specifications.
• Oversees training of departmental personnel in appropriate technique and related topics.
• Mentors and develops new department personnel including training in Standard Operating Procedures and training checklists.
• Assures department is equipped with functional, calibrated equipment and necessary supplies.
• Supervises investigations of non-conforming raw material, product or components and determines disposition.
• Works closely with Production, Quality Assurance, Chemistry, Maintenance, Metrology and Validation departments to ensure area environmental monitoring, product testing, PM, calibration and re-qualification schedules are met.
• Supervises qualification/requalification program for production and laboratory personnel.
• Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, EE and Investigation.
• Ensures adequate evaluation of new product processes.
• Supervises validation activities for responsible area.
• May act as a Manager in the absence of the manager.
• Represents the department in cross functional teams and meetings.
• Assumes other duties and responsibilities as assigned.

Description du poste

Fresenius Kabi USA is seeking a Supervisor in Microbiology to lead lab staff, ensure GMP and USP/EP compliance, and drive timely testing across environmental monitoring, materials, and finished products.

The role includes coaching, performance evaluations, SOP development, cross-functional collaboration, and mentoring new staff while maintaining calibrated equipment and testing programs.