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.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- 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
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.
Skills Required
- Experience in Microbiology and supervisor roles
- Knowledge of GMP, USP, and EP standards
- Proven ability to train and evaluate staff
- Strong analytical skills for quality trend analysis
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint





