Microbiology, Supervisor Overnight

• Supervises and schedules daily activities of lead/senior scientists, scientists, associate scientists, mentors and technicians.
• Effectively delegates to assure job objectives are met on a timely basis.
• Hires and oversees the training of department personnel. Assures steps are taken to maintain positive personnel morale and development. Conducts performance evaluations.
• Oversees microbiology department training of non-departmental personnel in aseptic technique, media fill execution and related topics.
• Assists management with development of training curricula and verifies department personnel maintain a current status on all training requirements.
• Supervises gowning and aseptic technique qualification/requalification program for production employees.
• Assures execution of monitoring and testing programs to assess the microbiology quality parameters of raw materials, components, in-process and finished goods, environmental systems and effectiveness of production processes.
• Establishes and meets goals for the timely release of product and performance of projects such as product transfers, equipment validation.
• Supports all Tech Transfer and I&D Validation activities, filter validation studies and plant equipment qualification and requalification.
• Ensures that a component, raw material, product or an environmental system not meeting specifications or limits is promptly investigated. Identifies possible root cause, corrective action needed and evaluates the impact upon the lot.
• Identifies significant adverse quality trends by preparing and analyzing summary reports and key process indicators. Addresses quality control test results, microbial profiles of environmental areas, and aseptic behavior.
• Generates new and updates Standard Operating Procedures. Ensures timely reviews of existing SOPs are assigned and completed.
• Maintains current knowledge of cGMPs and regulatory issues/guidelines.
• Assures department is equipped with functional, calibrated equipment and necessary supplies.
• Ensures daily quality concerns, questions, supporting data are being adequately addressed by department personnel.
• Ensures adequate evaluation of new product microbial specifications.
• Supervises validation and requalification activities for departmental equipment.
• Supervises and performs other duties as directed by management.
• 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

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

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.