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Job Summary
Responsible for 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. Collect and test utility samples such as WFI, clean steam and compressed gases. Monitors environmental conditions in laboratory areas during test sessions. Reports testing results and documents in compliance with cGMP and GLP standards. Provides support to Scientist, Lead Scientist, and Supervisor. Prepares media, reagents, sanitizing solutions and equipment for use in testing.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. Must be able to understand and follow company’s good documentation practices.
- 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.
Requirements:
- BS/BA degree in Science or related field.
- AS/AA degree with 1-3 years of relevant laboratory experience or progressive pharmaceutical lab experience.
- Some college with 5 or more 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.
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 contribution, and wellness 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.
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