COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
eGenesis is seeking an innovative QC Microbiology Specialist to lead and provide the technical and strategic oversight of eGenesis’ environmental monitoring program. In this position you will be responsible for hands on environmental monitoring sampling, testing, reporting and trending of eGenesis’ two GMP manufacturing facilities (Greater Madison Area and Northwest Indiana). You will ensure activities are executed in a cGMP compliant manner and will work collaboratively on implementation and maintenance of our contamination control program.
The ideal candidate will be independently motivated, a strong communicator and demonstrate proficiency in regulatory compliance. This position will be an onsite position in the Greater Madison Area.
PRIMARY RESPONSIBILITIES
- Coordinate the environmental monitoring (EM) program at both of eGenesis’ manufacturing facilities ensuring the collection, transport and processing of air, surface and personnel samples
- Manage the schedule for all routine and non-routine monitoring activities internally and with external contract laboratory
- Perform environmental monitoring sample collection (nonviable, viable, surface and personnel) as well as providing guidance and training on procedures to additional team members
- Keep complete and accurate documentation in electronic test methods
- Review and trend environmental monitoring data
- Support EM and laboratory deviations and identify and implement corrective actions to prevent reoccurrence
- Author, review, and/or approve data, SOPs, COAs, analytical methods, protocols, reports, deviations, and other quality records
- 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
- This position will require some travel (~20% of time) between manufacturing sites, but primary location will be in Wisconsin.
BASIC QUALIFICATIONS
- B.S./M.S. in Life Sciences or related field with 0-3 years of experience, in GMP QC Laboratory
- Proficient in microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique needed to perform EM in a GMP environment
- Strong knowledge of US and EU cGMP regulations/guidance
- The ability to work and lead in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential
- Effective communication skills, both verbal and written, at all levels and across various functions
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