QC Associate-Environmental Monitoring
Edison-New Brunswick Metro Area, NJ
The primary responsibility of this position is to perform routine Environmental Monitoring (EM) tasks within cellular therapy production areas. Responsibilities will include, but are not limited to, the following:
Coordinate with Production staff for daily EM test schedule and activities.
Collect EM samples (air, surface and personnel) from the controlled areas.
Support routine EM monitoring, aseptic process validation and aseptic qualifications.
Support sterility testing of PBMCs and drug product.
Process and incubate environmental monitoring samples.
Complete EM documentation in timely manner and enter into the EM database.
Perform trend analysis and reporting of EM data.
Support EM SOP revisions.
Participate in investigations and CAPA assignments as needed.
B.S. or BA degree (or equivalent) in Biochemistry, Biology, Microbiology, Chemistry, or related discipline and minimum 1 year of experience working in a regulated manufacturing environment. An equivalent combination of experience/education is acceptable.
Experience with environmental monitoring and aseptic processing is strongly preferred.
Understanding of and ability to apply the regulations associated with 21 CFR 210/211.
Able to do routine gowning.
Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
Current Schedule is Sun-Wed or Wed-Sat 4 x 10 Hours, may be required to work either shift initially and may change based on business needs.