Quality Consultant: Batch Release

Location: Allentown, PA
Department: Azzur Princeton, LLC

Job Description

We at Azzur Group are looking for an experienced Quality Associate focused on Batch Record Release  to join our team. 

Perform batch record review and disposition produced at external pharma manufacturing sites.

  • Maintain oversight for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly review batch documentation provided by external manufacturing site for compliance with cGMPs, client standards, and product specifications.
  • Ensure all required testing and documentation is provided and meets release requirements.
  • Perform batch disposition in accordance with client Supply Chain procedures
  • Manage/track OMCL/CBER samples from EM to final shipment to government facility
  • Generate OMCL/CBER protocols for lot release
  • Enter data into eLIMS
  • Alert Supervision of any nonconforming results, out of trend, or out of specification results
  • Support supply chain logistics for on time shipment from CMO to Warehouse
  • Minimum of 4 years working in a pharmaceutical regulated environment
  • Experience with pharmaceutical aseptic processing operations or quality assurance
  • Detailed knowledge of cGMPs related to pharmaceutical production
  • Strong interpersonal and written/oral communication skills
  • Ability to quickly process complex information and make critical decisions with limited information required
  • Advanced degrees are a plus and may reduce the experience required
  • Minimum of a Bachelor or equivalent discipline required
Preferred Experience:
  • Experience in vaccines production
  • Experience in the OMCL/CBER process for vaccine government approval/release
  • Proficient in applying process excellence tools and methodologies
  • Experience working with external manufacturers

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