Quality Control Associate - Environmental Monitoring - NJ in Warren, NJ at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


CORE JOB FUNCTIONS: 

  • 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. 

Skills/Knowledge Required: 

  • 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. 
  • 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. 

Working Conditions: 

  • The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment. 
  • 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 absolute must. 
  • Change to work timings and assigned tasks may occur at a very short notice to support business needs.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




913245