Position Summary:

The Specialist/Sr.  Specialist Quality Assurance Batch Release will partner with Manufacturing in the development and approval of Master Batch Records (MBR).  This position will also provide Quality reviews of and disposition of Executed Batch Records (EBR) and associated supporting documentation for the production of clinical products.  Additionally, this position will support any other GMP documentation reviews required for QA Batch Release.

The Specialist/Senior Specialist Quality Assurance Batch Release supports the drug product manufacturing process with the following responsibilities:

  • Responsible for the development/review/approval of MBRs

  • Responsible for the review and approval of EBRs

  • Work with internal manufacturing or CMOs as necessary to address any comments or corrections identified during the EBR review process

  • Confirm all deviations and investigation reports are closed prior to approval of EBRs

  • Collect and organize all required manufacturing documentation necessary for release of DS/DP

  • Maintain a batch record review schedule to ensure on-time product disposition

Additional responsibilities for the Manager/Sr. Manager Batch Release may include:

  • Manage CMO relationships with respect to Quality
  • Manage the Company Stability Program including Drug Substance, Drug Product for both internal and CMO manufacturing
  • Partner with QC on the review/approval of stability data
  • Review Stability protocols/reports as required

Minimum Education/Experience

  • Bachelor’s degree (or equivalent), preferably in scientific discipline or a health-related field and at least 2 years of experience reviewing Batch Documentation in the Pharmaceutical industry

  • Working knowledge of FDA and EMA GMP regulation and ICH guidance documents

  •  Experience in the manufacture of biopharmaceutical drug substance and drug products.

Other Qualifications

  • Strong organizational skills and attention to detail

  • Able to work effectively in a fast-paced, small start-up company environment

  • Self-motivated, self-disciplined and able to function independently as well as part of a team

  • Strategic agility, strong critical and logical thinking with ability to analyze problems

  • Strong ability to prioritize, multi-task, and work in an evolving environment

  • Excellent presentation and written/verbal communication skills

  • Excellent computer proficiency (MS Word, Excel, PowerPoint)