What are the responsibilities and job description for the Associate Scientist position at Integrated Resources, Inc ( IRI )?
Job Description: Job Duties:
- 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.