Quality Control Analyst in Summit, NJ at Pyramid Consulting, Inc

Date Posted: 11/21/2019

Job Snapshot

Job Description

Immediate need for a talented Quality Control Analyst with experience in the Pharmaceuticals Industry. This is a 12+ Months Contract opportunity with long-term potential and is located in Summit, NJ. Please review the job description below.
Job ID: 19-52747

Key Responsibilities:
  • 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.
Key Requirements and Technology Experience:
  • B.S. or BA degree (or equivalent) in Biochemistry, Biology, Microbiology, Chemistry,
  • 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.
  • 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.
Our client is a leading Pharmaceuticals Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.