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Fresenius Kabi

Global provider of therapies and devices

Associate Scientist Microbiology

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMelrose Park, IL, USA

About the Job

Requirements

  • A BS or BA degree in science or a related field, or an AS or AA degree with 1-3 years of relevant laboratory experience or progressive pharmaceutical laboratory experience, or some college with 5 or more years of relevant laboratory experience or progressive pharmaceutical laboratory experience.
  • Relevant experience may come from testing laboratories, food, cosmetic, veterinary, or hospital laboratories.
  • Strong verbal and written communication skills are required.
  • Attention to detail, people skills, and the ability to multitask are required.
  • Must be able to speak, read, write, and understand English to perform essential functions, including independently understanding policies, procedures, training materials, and workplace communications written in English.

Responsibilities

  • Collect and test routine environmental monitoring samples within aseptic processing fill lines, Isolator fill line, compounding, sterility suite, component preparation areas for aseptic lines, and clean room areas.
  • Collect and test utility samples such as water for injection, clean steam, and compressed gases.
  • Monitor environmental conditions in laboratory areas during test sessions.
  • Report testing results and document them in compliance with current good manufacturing practices and good laboratory practices.
  • Provide support to scientists, lead scientists, and supervisors.
  • Prepare media, reagents, sanitizing solutions, and equipment for testing.
  • Perform environmental monitoring for non-viable airborne particulate, viable airborne bioburden, viable surface bioburden, settle plate bioburden, and personnel monitoring in controlled areas.
  • Maintain gowning certification and apply good aseptic technique and clean room behavior.
  • Collect and process samples for water for injection, clean steam, and compressed gases according to standard operating procedures.
  • Perform bioburden, endotoxin, total organic carbon, and conductivity testing for utility samples.
  • Perform sub-culturing and Gram staining of microorganisms.
  • Perform growth promotion on incoming media to release it for monitoring use in the facility.
  • Maintain and review temperature records, laboratory cleaning records, and logbooks.
  • Enter results in the Laboratory Information Management System database and track microbiological results while following good documentation practices.
  • Compile and submit environmental monitoring data for critical system release.
  • Support scientists, lead scientists, and supervisors with testing and special projects, and independently carry out assigned special projects as required.
  • Assist with plant and laboratory equipment re-qualifications as directed.
  • Promptly report data discrepancies and out-of-limit conditions to supervision; complete documentation and assist scientists and lead scientists with investigations, incident reports, and corrective actions as assigned.
  • Assist with training new departmental personnel in standard operating procedures, training modules, and checklists.
  • Keep supervisory personnel informed of relevant events affecting department operations and performance.
  • Maintain compliance with company policies, training requirements, and current good manufacturing practices.
  • Follow safety requirements and maintain good housekeeping in laboratory areas, including 5S.

About the Company

Fresenius Kabi

Global provider of therapies and devices

Fresenius Kabi is a global healthcare company that provides medicines, medical devices, and services for the treatment of critically and chronically ill patients. Its portfolio includes biosimilars for autoimmune diseases and cancer, clinical nutrition products, infusion pumps and related disposables, blood collection bags and devices, and IV generics and fluids. It stands out with leading market positions in areas like blood collection and infusion materials and offers an integrated mix of pharma, nutrition, and MedTech offerings under the FutureFresenius strategy. Its goal is to shape the future of healthcare by expanding its global therapies and technologies, improving patient care, and delivering sustainable value for stakeholders.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Bad Homburg, Germany
Founded
1999

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