JOB FUNCTION: Scientific
JOB TYPE: Temp to Hire
LOCATION: Dunellen, NJ

MINIMUM EDUCATION: Bachelor's Degree
POSTED: May 16, 2019

Our client is a global company dedicated in providing quality products with advanced technological development to companies in the pharmaceutical industries worldwide.  They are currently seeking a Quality Associate to join their team.

Salary/Hourly Rate: DOE

Position Overview:  The Quality Associate primarily manages the cGMP programs in the areas of qualification, stability testing, validation, compliance, audits, in support of lab and production quality requirements. 

Responsibilities of the Quality Associate:

  • Review and approve batch records, quality documents including process master documentation, product specifications, change control documents, qualification documents, validation documents, and process related documents
  • Review and authorize orders re-working and processing
  • Authorize Certificate of Analysis and release products upon completion
  • Author and revise SOPs and quality reports
  • Evaluate and approve equipment cleaning, equipment qualification protocols and reports, process validation protocols and reports
  • Manage stability program including approval of stability data report
  • Assist in client and FDA audits and inspections
  • Conduct internal audit and inspections to ensure cGMP compliance

Qualifications for the Quality Associate:

  • Degree in Chemistry, Chemical Engineering or related disciplines
  • Experience in pharmaceutical manufacturing environments highly preferred
  • Familiar with quality documents – process, operations, equipment and cleaning validation, and quality system management
  • Good understanding of cGMP applicable in production (processing) and QC
  • Familiar with ICH guidelines
  • Hands-on experience in QC or analytical labs a plus
  • Project management experience a plus

Education Requirements:

  • Degree in Chemistry, Chemical Engineering or related disciplines

Benefits:  Eligible for Atrium Care Package 


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