Fresenius Kabi USA, LLC is hiring: Overnight Associate Scientist in Melrose Park

Job Summary

Responsible for the collection and testing of routine environmental monitoring samples within aseptic processing fill lines, isolator fill lines, compounding, sterility suite, and component preparation areas for aseptic lines (Building A) and clean rooms in the new expansion, Building B. Collect and test utility samples such as WFI, clean steam, and compressed gases. Monitor environmental conditions during testing sessions and report results in compliance with cGMP and GLP standards. Support Scientists, Lead Scientists, and Supervisors. Prepare media, reagents, sanitizing solutions, and equipment for testing.

Salary Range

$30.00-$35.00 per hour. Final pay will depend on experience, education, knowledge, skills, and abilities.

Benefits

Our comprehensive benefits include a 401(k) plan with company contributions, paid vacation, holidays, personal days, employee assistance program, and health coverage (medical, dental, vision, prescription drugs).

Responsibilities

1. Perform environmental monitoring for non-viable airborne particulate, viable airborne bioburden, surface bioburden, settle plates, and personnel monitoring.
2. Maintain gowning certification and apply good aseptic technique and clean room behavior.
3. Collect and process samples for WFI, clean steam, and compressed gases following SOPs.
4. Conduct bioburden, endotoxin, TOC, and conductivity testing on utility samples.
5. Perform microorganism sub-culturing and Gram-staining.
6. Perform growth promotion tests on incoming media.
7. Maintain and review temperature records, lab cleaning records, and logbooks.
8. Input results into the Laboratory Information Management System (LIMS) and track microbiological data, following good documentation practices.
9. Compile and submit environmental monitoring data for critical system release.
10. Support testing and special projects; carry out independent projects as assigned.
11. Assist with plant and lab equipment re-qualifications.
12. Report data discrepancies and out-of-limit conditions; assist with investigations and corrective actions.
13. Train new personnel on SOPs and training modules.
14. Inform supervisory personnel of relevant operational events.
15. Maintain compliance with policies, training, and cGMPs.
16. Follow safety protocols and maintain good housekeeping, including 5S practices.

Additional Information

We offer a competitive salary and benefits package, including medical, dental, vision, life insurance, disability, 401(k) with company contribution, and wellness programs.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or veteran status.

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