Overview
Quality Assurance Inspector (QA Inspector) Jobs in United States at Heat Group Ltd
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
B.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
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Parental leave
Referral program
Vision insurance
Schedule:
Monday to Friday
Work Location: In person
Title: Quality Assurance Inspector (QA Inspector)
Company: Heat Group Ltd
Location: United States
