Job Description
Job Description
Responsibilities and Duties:
- Execute daily environmental sampling for dynamic or static environmental monitoring (EM) of cleanrooms.
- Perform incubation, enumeration and gram staining of microbiological organisms.
- Perform growth promotion testing for media release.
- Document and maintain required QC records and logs.
- Trend and analyze EM data.
- Report and participate in the investigation of EM excursions, deviations, out-of-specification results, etc.
- Perform preparation and shipment of EM related samples to external contract testing laboratories when necessary.
- Write technical documents such as reports, change controls, and SOPs.
- Perform visual inspections and release testing on materials as needed.
- Other duties as assigned.
Qualifications and Requirements:
- Bachelor of science in a Life Sciences or related discipline.
- 2-5 years of relevant experience working in a Quality Control work environment, preferably in a regulated environment in the pharmaceutical/biotech industry.
- Working knowledge of cGMP regulations.
- Experience working and gowning in a cleanroom environment.
- Aseptic behaviors training