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ElevateBio Quality Systems Administrator in Waltham, Massachusetts

Title: Quality Systems Administrator

Location: Waltham, MA

Reports to: Sr. Manager Quality Assurance

The Role:

ElevateBio is looking for Quality Systems Administrator, to join their growing Quality group. The GxP Systems Administrator is a knowledgeable individual that configures, supports, and maintains regulated information systems in accordance with ElevateBio Policies, SOPs, and industry best practices. The GxP Systems Administrator will also collaborate with the other departments to identify requirements and implement systems in accordance with appropriate change controls in order to meet the requirements. The position supports compliance responsibilities including, but not limited internal system audits. The GxP System Administrator works with and supports GMP Manufacturing, Quality Control, Quality Assurance, Validation, among other teams across ElevateBio BaseCamp.

Here?s What You?ll Do:

  • System Administrator responsible for Veeva Vault and KNEAT Enterprise Cloud Systems, including User Administration and System Configuration.

  • Create and maintain SOPs and procedures related to GxP systems.

  • Follow Quality process to maintain systems in a validated state and ensure appropriate GxP systems are in compliance with 21 CFR part 11.

  • Collaborate with vendors, quality personnel, and IT colleagues to implement and support GxP systems in a controlled laboratory and manufacturing environment.

  • Assist with change control impact assessments for GxP systems changes.

  • Provide support during new systems implementation, overseeing design, development, or configuration to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.

  • Support Periodic Reviews to confirm computerized systems are compliant with company procedures and regulatory agency requirements.

  • Consult with CSV and IT Management to resolve complex issues in a timely manner.

  • Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization.

    Requirements:

  • +3 years of hands-on Veeva Vault experience maintaining quality assurance of an IT environment.

  • Bachelor's Degree in Computer Science, Computer Information Systems (CIS), or related field

  • Understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Change Control Working knowledge of Active Directory/LDAP and Windows Security.

  • Experience with one or more of the following: software testing and deployment, user access review, asset lifecycle management, and data archival and backup strategies.

  • Detail-oriented with problem solving, analytical, and critical thinking skills.

  • Excellent collaboration and communication skills

  • Ability to manage competing priorities and flexibility to shift workload when needed

    Why join ElevateBio?

    ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.

    At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

    Our Vision: Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

    ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person?s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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