SENIOR SPECIALIST, DATA INTEGRITY

Company: Bristol-Myers Squibb
Location: Summit
Posted on: October 19, 2024

Job Description:

Senior Specialist, Data IntegrityWorking with Us

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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.The Senior Specialist, Data Integrity role is responsible for assisting with the implementation and management of Bristol Myers Squibb's GMP Data Governance and Data Integrity program at the Summit West, NJ CAR T manufacturing facility. This includes implementing documentation and processes in support of the laboratories, manufacturing, and GMP support areas.Shift Available:
Mon-Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.Responsibilities:

• Responsible for executing data integrity documentation periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.
• Responsible for assisting with the implementation of Global Data Integrity Processes at the site and ensuring that Global programs are implemented on-time.
• Assist in ensuring local site activities are harmonized with Global DG/DI standards.
• Provide feedback and support to GMP areas in scope during process improvement, while ensuring compliance with Global DG/DI policies and standards.
• Responsible for ensuring systems at Summit West, NJ CAR T facilities comply with data life cycle requirements from initial data creation/recording to archival and decommissioning.
• Responsible for creating and executing data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
• Drive mitigation and remediation when data integrity gaps are identified.
• Work with functional area SMEs at Summit West CAR T facility to ensure data risks are identified, remediated and prevented.
• Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement.
• Provide the GMP functions any updates regarding data integrity regulations that they may be impacted by.Knowledge & Skills:
  • Must have familiarity with GMPs, Quality, and Data Integrity principles.
  • Must be familiar with system validation principles.
  • Must be familiar with the ALCOA+ principles and their application to both electronic and paper data.
  • Must be able to effectively interpret problems and communicate in an impactful manner to management and the group.
  • Must provide guidance to other employees in the interpretation and correction of data integrity issues.
  • Must be able to critically review and author technical reports.
  • Completes routine tasks with little to no supervision; Confident in making decisions in their subject matter area.
  • Drives continuous improvement projects and improve efficiency and productivity within the group or project.
  • Support and lead cross functional project teams driving performance and results.
  • Strong project management skills with the ability to effectively communicate.
  • Recognizes data integrity risks and ensures remediation efforts are driven to completion.Basic Requirements:
    • Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
    • Minimum 3-5 years relevant work experience with data integrity.
    • Minimum 1-2 years equipment and system validation experience.
    • Experience with PC based office computers and standard Microsoft Office applications.Preferred Requirements:
      • Preferred experience with Risk Management Principles and projects.
      • Preferred experience with electronic document and data management systems.Working Conditions:
        • Work is performed in a typical office environment, with standard office equipment available and used.
        • Work is generally performed seated but may require standing and walking for up to 10% of the time.
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Keywords: Bristol-Myers Squibb, Hamden , SENIOR SPECIALIST, DATA INTEGRITY, Other , Summit, Connecticut