Overnight Associate Scientist (12-Hour Shifts)
About The Position
The Overnight Associate Scientist will be 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. This role also involves collecting and testing utility samples such as WFI, clean steam, and compressed gases, and monitoring environmental conditions in laboratory areas during test sessions. The Associate Scientist will report testing results and document them in compliance with cGMP and GLP standards, while providing support to the Scientist, Lead Scientist, and Supervisor. Responsibilities include preparing media, reagents, sanitizing solutions, and equipment for testing.
Requirements
- Bachelors Degree in Science related field
- Associates Degree in Science related field 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
- Must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
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.
- 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
Benefits
- 401(k) plan with company contributions
- Paid vacation
- Paid holiday
- Paid personal days
- Employee assistance program
- Medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Wellness program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
