Quality Control Microbiology Coordinator
EGenesis
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Middleton, WI, USA
Posted on Sep 1, 2023
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 Coordinator to lead and provide the technical and strategic oversight of eGenesis’s environmental monitoring program. In this position you will be responsible for leadership as well as hands on environmental monitoring sampling, testing, reporting and trending of both eGenesis GMP manufacturing facilities (Middleton, WI and 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. The ideal candidate will be independently motivated, a strong communicator and demonstrate proficiency in regulatory compliance.
PRIMARY RESPONSIBILITIES
- Coordinate the environmental monitoring (EM) program at both 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.
- Review and trend environmental monitoring data.
- Support EM and laboratory deviations. 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.
- Serve as onsite QC contamination control representative and work cross functionally to maintain and enhance cleaning/disinfection program, material/equipment and gowning programs.
- This position will require some travel (~20% of time) between manufacturing site but primary location will be Middleton, WI.
BASIC QUALIFICATIONS
- BS/MS in microbiology, biology or a related scientific discipline with 3-5 years industry experience in a 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.
This job is no longer accepting applications
See open jobs at EGenesis.See open jobs similar to "Quality Control Microbiology Coordinator" Khosla Ventures.