Overnight Associate Scientist Microbiology

Fresenius Kabi•Melrose Park, IL

2d•Onsite

About The Position

This position is responsible for the collection and testing of routine environmental monitoring samples within aseptic processing fill lines, Isolator fill line, compounding, sterility suite, and component preparation areas for aseptic lines (Building A) and clean rooms areas in new expansion Building B. The role also involves collecting and testing utility samples such as WFI, clean steam, and compressed gases, monitoring environmental conditions in laboratory areas during test sessions, and reporting testing results while documenting in compliance with cGMP and GLP standards. The Associate Scientist provides support to the Scientist, Lead Scientist, and Supervisor, and is responsible for preparing media, reagents, sanitizing solutions, and equipment for testing.

Requirements

BS/BA Degree in Science or related field or AA/AS degree
1-3 years of relevant laboratory experience or progressive pharmaceutical lab experience.
Applicable industries include but are not limited to testing laboratories, food, cosmetic, veterinary, or hospital laboratories.
Strong verbal and written communication skills are essential.
Attention to detail, people skills and ability to multi-task are essential for success.
Must be able to understand and follow company’s good documentation practices.

Responsibilities

Perform environmental monitoring in controlled areas for non-viable airborne particulate, viable airborne bioburden, viable surface bioburden, settle plate bioburden and personnel monitoring.
Maintain gowning certification and apply good aseptic technique and clean room behavior.
Collect and process samples for water for Injection (WFI), clean steam and compressed gases according to established standard operating procedures.
Perform bioburden, endotoxin, Total Organic Carbon (TOC), and conductivity testing for utility samples.
Perform sub-culturing and Gram-staining of microorganisms.
Perform growth promotion on incoming media to release for monitoring use in the facility.
Maintain and review temperature records, lab cleaning records, and logbooks.
Input results in Laboratory Information Management System (LIMS) database and track microbiological results.
Compile and submit environmental monitoring data for critical system release.
Supports Scientist/ Lead Scientist/ Supervisor with testing and special projects.
Carries out special projects independently as required and assigned by supervision.
Aids with plant and laboratory equipment re-qualifications as directed.
Promptly reports data discrepancies and out of limit conditions to supervision.
Carries out documentation, and assist Scientist and Lead Scientist with investigation, incident reports and corrective actions as assigned.
Assists in training new departmental personnel in standard operating procedures, training modules and checklists.
Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department.
Maintains compliance with company policies, training requirements, cGMP’s.
Follow safety requirements, maintains good housekeeping of lab areas including 5S.