Quality Control Associate- Environmental Monitoring
Newark 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.
Collection of EM samples (air, surface and personnel) from controlled areas.
Processing, incubation and evaluation of environmental monitoring samples.
Organization and completion of EM documentation and entering of data into the EM database.
Perform trend analysis and lot release reporting of EM data.
Support SOP revisions.
Participate in investigations and CAPA assignments as needed.
Monitor DQC inventory of reagents and supplies. Re-order as needed.
Understanding of and ability to apply the regulations associated with 21 CFR 210/211.
Able to do routine gowning.
Responds to challenges and additional projects in an understanding, positive, and objective manner.
Adaptable to dynamic conditions, work practices, and project timelines.
Able to communicate effectively with GPDO functional areas.
Fosters teamwork and promotes an environment that motivates others to achieve our goals.
The incumbent will be required to wear uniform/ PPE to work in the manufacturing or
The incumbent may be required to stand and walk for extended amount of time.
The incumbent may be required to work hazardous materials.
Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an
Change to work timings and assigned tasks may occur at a very short notice to support business
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.