Quality Assurance Senior Engineer, DSM Disposition

1 day ago

Holly Springs North Carolina, United States Fujifilm Full time
About This Role

The Quality Assurance Senior Engineer, DSM Disposition, is a critical position responsible for establishing and maintaining a robust and efficient disposition program at our site. This role ensures the quality and compliance of product disposition and identifies opportunities for continuous improvement.

Key Responsibilities
  • Perform and manage batch release activities for production, including review of batch records, analytical data, certificates of analysis, and other documents.
  • Participate in establishing programs and systems to ensure all GxP requirements associated with the disposition of product batches are phase appropriate and complied with.
  • Ensure Disposition process and interdependencies are defined and well understood, and leverage data and technology to drive compliance, efficiency, and monitoring.
  • Ensure integration of Disposition process with other Quality Systems (Deviation/CAPA, Change Control, Validation).
  • Provide guidance and quality oversight of cGMP activities supporting all material and product disposition, including drug substance manufacturing, labeling, batch record review, and lot Disposition.
  • Provide status reports and quality metrics to support management review process.
  • Partner with cross-functional teams to ensure products are delivered on time and within specification.
  • Provide input, review, and approval for complex/critical deviations, CAPAs, change controls, or other quality records in support of lot Disposition.
  • Serve as disposition SME with regulators, clients, and company management.
  • Perform review and approval of Quality documentation, such as equipment, system, process, and method validations, qualification and validation reports, master batch records, validation master plans (VMPs), risk assessments, and technical reports.
  • Assist QA senior management with departmental needs.
Requirements
  • Bachelor's in Life Sciences or Engineering or equivalent with 9+ years of applicable industry experience OR
  • Masters in Life Sciences or Engineering and 7+ years of applicable experience OR
  • PhD in Life Sciences or Engineering and 5+ years of applicable experience
  • Previous experience in batch disposition
Preferred Requirements
  • Previous experience with Smartsheet, Trackwise, MasterControl, Veeva, and/or Kneat validation software
  • Previous experience with one or more of the following processes: cell culture/upstream processes, large scale recovery/downstream processes, aseptic processing
  • Experience with complex projects to keep work pace and meet deadlines with good organization and planning skills
  • Training and/or familiarity with Quality Risk Management principles

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