Quality Control Associate- Environmental Monitoring
Newark Metro Area, NJ
Intended to describe the general nature and level of work being performed by the person assigned to this position. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by the management.
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.
Support Microbiology Lab activities when needed.
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.
Respond to challenges and additional projects in an understanding, positive, and objective manner.
Adaptability to dynamic conditions, work practices, and timelines.
Able to communicate effectively with various teams.
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 an extended amount of time.
The incumbent may be required to work with hazardous materials.
The work will be on a rotating shift basis that includes weekends. Rotation of the shift and hours of the shift may change to accommodate business needs.
The current shift is three 12 hour days on a rotating basis including weekend. (3 on, 2 off, 3 on, 2 off, 3 on, 8 off and repeat). Shifts may change to meet business needs.
Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
Change to work timings and assigned tasks may occur at a very short notice to support business needs.
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.