SUPERVISOR, MICROBIOLOGY

Fresenius Kabi USA; North Carolina; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Job summary

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.

Responsibilities

• 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.

Job description

Job Summary This position reports to the Manager, Microbiology and is responsible for effectively hiring, developing, coaching, counseling, managing and motivating staff. The supervisor is responsible for supervising the activities of lab technicians up through Lead Scientist levels. They are responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as USP and EP. The supervisor identifies areas for validation and/or improvement and develops protocols for same. The supervisor keeps the manager informed of all departmental activities and product related events.

Salary Range: $73,614 - $103,528 Position is eligible to participate in a bonus plan with a target of 6% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage

Responsibilities

• 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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Contact us at [e-mail].