at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States
Job Description
Job Summary
The Associate Supervisor in Microbiology is a position intended as a developmental position for an incumbent whose career path is to move into laboratory supervision/management. The individual spends most of their time focused on assuming supervisory tasks to develop management skills and is responsible for training less experienced analysts, conducting/documenting lab investigations, assisting Microbiology Supervisor in leading lab operations in compliance with cGMP and other laboratory regulations and testing of complex routine/non-routine samples.
Responsibilities
Oversee a selected group of analysts under direct guidance of lab supervisor. Performs department-wide training on issues that arise (i.e. corrective actions, new SOPS) Review and approve test data including approval in LIMS Supervises laboratory area when supervisor is out of the office Teaches or coordinates instruction of training modules and laboratory techniques to new analysts and to ensure cross training of more experienced team members. Creates testing schedule for analysts and helps to maintain a fully compliant laboratory. Performs checks and reviews of laboratory documentation to ensure error-free reporting. Displays expertise in documentation requirements of department as well as cGMP, GDP/GLP practices. Follows up with staff on status of testing to ensure timely completion of tasks. Assists supervisor in ensuring timely completion and compliance in Out of Limits (OOL), Out of Specification (OOS), Out of Trend (OOT), and Deviation Investigation and resolution. Revises and updates Finished Product Specifications, Standard Operating Procedures, Methods of Analysis, Training Modules, and Protocols as needed. Will assist in development of testing methods and procedures in accordance with established guidelines. Acts as a subject matter expert on test methods, and laboratory instrumentation in the QC laboratory. Performs required tests on routine and non-routine samples to support the Quality Control and Production Departments as assigned. Performs peer review of data to ensure compliance and accuracy as well as conformance to specifications. Performs technical review of documentation, procedures, reports etc. 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.
Bachelor's degree in microbiology, Biology, or other relevant Life Science discipline Requires 3 years of progressive responsibility in support of pharmaceutical manufacturing. Some supervisory experience preferred. Working knowledge and experience with cGMP rules, GLP/GDP, USP and ICH guidelines is required. Excellent written and oral skills. Planning and organizational skills necessary for primary responsibilities. Excellent written and oral communication skills are required. Strong attention to detail, people skills and ability to multitask are essential for success Planning and organizational skills necessary for primary responsibilities Must be proficient in Microsoft Office (Word, Excel, Powerpoint)
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 regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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.
