eGenesis
Quality Control Microbiology Specialist
Greater Madison, WI Area
Sponsorship not specifiedDetected 27 days ago
GMPCommunication
About the role
- In this position you will be responsible for hands-on environmental monitoring sampling, testing, reporting and trending of eGenesis GMP manufacturing facilities in Rensselaer, IN.
- You will ensure activities are executed in a cGMP compliant manner and have the opportunity to work collaboratively on implementation and maintenance of our contamination control program.
- This position will be in the Greater Madison Area in Wisconsin.
Responsibilities
- Manage the schedule for all routine and non-routine monitoring activities internally and with external contract laboratory.
- Perform environmental monitoring sample collection (nonviable, viable, and surface) as well as providing guidance and training on procedures to additional team members.
- Support EM and laboratory deviations. Identify and implement corrective actions to prevent reoccurrence.
- Work collaboratively with QC contamination control representative and work cross functionally to maintain and enhance cleaning/disinfection program, material/equipment and gowning programs as applicable.
Requirements
- B.S./M.S. in Life Sciences or related field with 0-3 years of experience, in GMP QC Laboratory.
- Strong knowledge of US and EU cGMP regulations/guidance.
- The ideal candidate will be independently motivated, a strong communicator and demonstrate proficiency in regulatory compliance.
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