at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States
Job Description
Job Summary
Responsible for the overall operation of the Quality Control Bacterial Filter Retention (BFR) Microbiology Laboratory, Aseptic Process Simulation Program, and Aseptic Mentor Program, and ensures the programs are conducted in compliance with Fresenius Kabi USA and regulatory microbiology quality standards. Responsible for oversight of aseptic technique training and monitoring program of individuals qualified to work in aseptic environments. Responsible for managing the Aseptic Process Simulation qualification and requalification program for 11 aseptic filling lines. Ensures all support functions for maintaining operational compliance requirements are routinely carried out and met. The individual will provide guidance and support to the BFR Laboratory team and Aseptic Mentor team to meet plant and department goals.
Responsibilities
Directs and prioritizes the functioning of multiple teams supporting the sterility assurance program for production processes to demonstrate that product meets Fresenius Kabi USA and FDA regulatory quality requirements.
Oversees the administration of approximately 12-15 microbiologists, aseptic mentors, and supervisors to ensure that members are adequately trained, developed and motivated, and adhere to quality performance standards.
Determines the strategic planning for development of aseptic process simulation programs and aseptic production procedures to meet compliance objectives.
Directs all aspects of the aseptic process simulation programs for both traditional aseptic cleanrooms and isolator technology. Writes, reviews, and approves investigations, protocols, SOPs, and work instructions related to aseptic processing and other microbiology-related processes.
Coordinates with the Global Compliance Center, Microbiology, to ensure the media fill program meets global, FDA, and EU compliance requirements.
Plans and coordinates training, leading to the development of cross-trained, self directed work teams in line with total quality management concepts.
Ensures the department is adequately equipped with up-to-date instrumentation and equipment that is properly calibrated and serviced. Maintains knowledge of state-of-the-art technologies and instrumentation and implements or acquires these as needed.
Develops and implements programs for trending related to aseptic process simulations and aseptic mentor risk probability number data. Oversees the preparation of reports and analyzes to identify adverse trends. Leads meetings with site production and quality leadership, identifying trends and recommending improvements.
Establish test protocol designs for scientific validation of test methods, equipment and instruments used in testing or monitoring aspects of product quality.
Evaluates and decides upon corrective actions to be taken in response to excursions in controlled environmental conditions to which products are exposed so that product sterility assurance is maintained.
Initiates ideas and provides assistance in the development of facility improvements and maintenance of cGMP conditions.
Interacts with director and executive levels in R&D, manufacturing, and engineering personnel to provide technical evaluation and quality control recommendations for new processes relevant to microbiological concerns or to troubleshoot existing processes.
Secures technical expert advice and interpretation on compendial test issues and other laboratory methodology issues from personnel in the industry and at the United States Pharmacopeia and the FDA.
Develops, administers, and maintains the operating and capital budgets for the department.
Represents the department as subject matter expert with active participation in cGMP inspections and other audits.
Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management System including Environmental and Energy Policy.
Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
JOB REQUIREMENTS
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 match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without... For full info follow application link.
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, disabilities, or protected veteran status.
