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ElevateBio Manager/Senior QA Specialist, Document Control in Waltham, Massachusetts

Title: Manager/Senior QA Specialist, Document Control

Location: Cambridge, MA

Reports to: Sr. Manager Quality Assurance

The Role:

ElevateBio is looking for a Sr. QA Specialist, to join their growing Quality group. In this role t he individual will manage the Electronic Document Management System (EDMS), to ensure all ElevateBio’s record and documentation systems are in compliance with US and international regulations, laws, and guidelines. The Senior Quality Specialist will be accountable for management of the EDMS, as well as support training, audits and inspections, and continuous improvement.

Here’s What You’ll Do:

  • Manage the ElevateBio GxP Electronic Documentation Management Systems (EDMS)

  • Coordinate and support the creation, revision, distribution, and maintenance of controlled documentation (i.e., SOPs, regulatory submission documents, trial master file documentation, etc.)

  • Work directly with the QA and Regulatory departments and other ElevateBio departments to revise, issue and track controlled documents and records to meet timelines. Provide status updates and reminders when necessary.

  • Ensures basic grammatical accuracy and completeness when revising documents.

  • Oversee document change control processes

  • Conducts internal audits of the electronic document management system and documents where needed to ensure compliance to applicable ElevateBio Policies and SOPs.

  • Support client and regulatory (FDA, EMA), inspections when necessary.

  • Compile and provide applicable metrics for periodic Management review.

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

    Requirements:

  • Bachelor’s Degree and +2 years of experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries

  • Prior experience with an Electronic Document Management Systems and Trial Master Files

  • Experience with the establishment of an eTMF using the Trial Master File Reference Model

  • Microsoft Word and Microsoft Access experience

  • Knowledge of both domestic and international GMP, GCP and other relevant regulations.

  • A team player, who listens effectively and invites response and discussion

  • A collaborator who communicates in an open, clear, complete, timely and consistent manner

    Desired Experience and Skills:

  • Two plus years prior experience with Veeva QualityDocs, Training and eTMF systems

  • Clear understanding of the regulations and guidance that govern Good Documentation Practices, as well as Electronic Records and Electronic Signatures.

  • Two plus years prior experience with Regulatory documentation and Regulatory submissions

    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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