Join a growing gene therapy Biologics company as a QC Microbiologist.
About the Role
The QC Microbiologist will independently plan, coordinate, and execute the overall Quality Control activity of 2 new Cleanroom suites opening soon for new production. He/She will conduct sampling, bench testing, and gown qualification directly for the cleanrooms.
Responsibilities
- Independently perform environmental testing required for the cleanroom (ISO 7 suites) including environmental monitoring (particle counts), gram staining, sterility testing, and bacterial endotoxin testing.
- Conduct gown qualification / gown testing for cleanroom personnel.
- Evaluate and interpret results of analytical/microbiological testing performed by third parties.
- Work with the QA department on cleanroom performance qualification.
- Establish sampling plans and collect microbial samples as required.
- Trend results of environmental monitoring and determine actions.
- Responsible for comprehensive recording of test results.
- Participate in all aspects of cleanroom out of specification, deviations, and contamination event investigations.
- Ensure that the necessary microbiology tests are done according to the test specification, test method, and working instruction to ensure on-time release for cell products.
Qualifications
- BS degree and 3+ years of biologics or pharmaceutical Quality Control microbiology and Environmental Monitoring experience.
- Hands-on GMP Environmental Monitoring experience including sampling, particle counts, EM testing, gram staining.
- Ability to work independently.
Highly Preferred
- Sterility testing, bioburden, and bacterial endotoxin testing.
- Experience with environmental monitoring of Clean room (level 5 or 7).
- Aseptic gowning and gowning qualification.
