Quality Control Technician

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 Quality Control Technician to provide day to day technical support of eGenesis’ environmental monitoring program. In this position you will be responsible for hands on environmental monitoring sampling, testing, reporting and trending of eGenesis’ GMP manufacturing facility (Norwest Indiana). You will ensure activities are executed in a cGMP compliant manner and will work collaboratively on support 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 Northwest, IN.

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 as needed
• Work collaboratively with QC contamination control representative and work cross functionally to support cleaning/disinfection program, material/equipment and gowning programs as applicable

BASIC QUALIFICATIONS

• B.S./M.S. in Life Sciences or related field with 0-3 years of experience, in GMP QC Laboratory
• Familiarity with microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique in a GMP environment preferred
• Knowledge of or interest in learning US and EU cGMP regulations/guidance required
• 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

TOTAL REWARDS

• eGenesis is proud to offer competitive compensation including annual base salary and annual bonus. We take great care in offering our employees excellent benefits including:
• Medical insurance (80% company paid)
• Dental insurance (80% company paid)
• Vision insurance (100% company paid)
• 401k with a company match
• Paid time off and paid sick time
• Paid holidays