Data Stewardship and Compliance Business Analyst

3 weeks ago

Summit, United States MyKelly Full time
Data Stewardship and Compliance Business Analyst
Location: Summit West, NJ or Devens, MA - Hybrid
The Data Stewardship and Compliance Business Analyst, Cell Therapy Manufacturing Technology work with a cross-functional team responsible for supporting the production of personalized cell therapy products for global commercial supply. This role will work with peers in the Technical Operations team and site MS T cell therapy to compile and ready data for regulatory filings and to support validation activities. This position interacts heavily with the Cell Therapy production facilities in NJ, WA and MA to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. The role will benefit from a strong understanding of working within quality document systems and managing the on-time document review cycles for a cross functional team. This position is based at either Summit, NJ or Devens MA.
Key Responsibilities
  • The Data Stewardship and Compliance Business Analyst is closely partnered with the Technical Product Team Lead and Stewards to enable effective execution of strategy and plans.
  • Compile and efficiently manage process data from various data owners to enable effective data management.
  • Coordinate with cross-functional and site teams to ensure accurate and timely compilation of data. Collect data from multiple sources and conduct data verification processes to ensure accuracy and integrity.
  • Lead quality system document review and routing.
  • Follow up with reviewers and approvers in the document system to ensure timely completion of document reviews and approvals.
  • Manage project timelines and scenario planning to ensure timely completion of tasks.
  • Handle all meeting logistics, including the creation of agendas, meeting minutes, and follow up actions.

Experience / Qualifications:
  • Bachelor s degree in engineering or relevant scientific discipline with at least 2 years of relevant experience.
  • Highly motivated self-starter that works well both in teams as well as independently.
  • Strong experience in compiling and managing process data from various sources.
  • Proficiency in data analysis, data verification, and ensuring data accuracy and integrity.
  • Background in GXP preferred.
  • Demonstrated experience in coordinating with cross-functional and site teams to ensure accurate and timely compilation of data.
  • Ability to manage project timelines, prioritize tasks, and handle multiple projects simultaneously.
  • Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment. Excellent communication skills to effectively coordinate with various stakeholders, including data owners, cross-functional teams, and reviewers/approvers.
  • Strong collaboration skills to work in a team-oriented environment.
  • Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems Veeva Vault preferred.
  • Experience in data analysis programs like JMP, R, or Excel. Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement.
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