at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States
Job Description
Job Summary
The EM Manager is responsible for the overall operation of the Quality Control Environmental Monitoring program at the Melrose Park Manufacturing Plant. Manages the environmental monitoring program to ensure products have been produced in compliance with Fresenius-Kabi and regulatory microbiology quality standards. Responsible for oversight of 24/7 environmental monitoring across traditional aseptic and isolator filling lines and supporting environmental systems. Ensures all support functions for maintaining operational compliance requirements are routinely carried out and met. Directly supports meeting the company's and department's strategic plans.
Responsibilities
Directs and prioritizes the functioning of multiple shift work teams within the EM Microbiology Department to provide for the timely and accurate environmental surveys of all manufacturing controlled areas and specified utilities. Ensures that all departmental activity meets Fresenius-Kabi USA and FDA regulatory quality requirements.
Oversees the administration and growth of approximately 20 EM staff personnel including shift supervisors to ensure that members are adequately trained, developed and motivated, and adhere to quality performance standards.
Writes, reviews, and approves investigations, protocols, SOPs, and work instructions related to environmental monitoring and other microbiology-related processes, including media fill protocols and reports.
Coordinates and ensures timely closure of documents to support compliance and release of products to patients.
Contributes to the communication and support of the company's core values. Promotes support for the greater success of the company's and department's goals and objectives.
Plans and coordinates training schemes 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.
Directs the qualification / requalification of controlled access areas and utility systems to ensure compliance to ISO 14644, EU Annex 1, and FDA regulatory standards.
Ensures test protocol designs for scientific validation of survey and recovery methods, equipment and instruments used in testing or monitoring are prepared and timely executed.
Evaluates and implements necessary corrective actions to be taken in response to environmental monitoring adverse trends and 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 manager and director levels in R&D, manufacturing and engineering departments to provide technical evaluation and quality control recommendations for new processes relevant to environmental microbiology concerns or to troubleshoot existing processes.
Secures technical expert advice and interpretation on compendial issues related to environmental surveys and other laboratory methodology issues from personnel in the industry and at the United States Pharmacopeia and the FDA.
Ensures all required materials for executing the EM programs are obtained from qualified vendors. Works to promote cost control of purchased goods and services.
Develops, administers, and maintains the operating and capital budgets for the environmental monitoring department.
Represents the department with active participation in cGMP inspections and other audits.
Responsible for all other EM and aseptic mentor program related projects as assigned.
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
Bachelor's degree in life science with emphasis or major in Microbiology
Minimum of 5 years of progressive quality control/microbiology experience with at least one year in a leadership role.
Previous laboratory experience, preferably in pharmaceutical manufacturing or at least in a related industry having quality control requirements is desired.
Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience.
Possess ability to interface and communicate effectively with a variety of levels of personnel from bench level to upper management levels.
Must be able to... 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.
