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QA Manager, Document Control (Contract)

Adverum Biotechnologies, Inc.Redwood City, CA

About The Position

Adverum Biotechnologies, Inc., a subsidiary of Eli Lilly and Company, is a clinical-stage company focused on gene therapy for ocular diseases. The company is seeking a QA Manager, Document Control to manage and support its document control and quality systems. This role involves system administration of MasterControl EQMS, training, and oversight of various quality processes such as deviations, CAPAs, change control, and lot disposition.

Requirements

  • Bachelor's degree in a Life Science or other relevant discipline preferred.
  • 7+ years of work experience with an electronic document management system.
  • 5 years of Document Control, Training Management, or Quality System experience.
  • Experience with implementation/maintenance of electronic document management systems, curriculum design, and training.
  • Proficient in MS Office (Word, Excel, PowerPoint) and Adobe Acrobat.
  • Knowledge of GMP regulations.
  • Ability to communicate well with all levels of staff.
  • Strong critical thinking, problem-solving, and exceptional attention to detail.
  • Ability to manage and prioritize multiple projects/tasks with minimal supervision and adapt to changing priorities.

Responsibilities

  • System administration of MasterControl EQMS.
  • Lifecycle management of controlled documents (creation, review, approval, retirement).
  • Lifecycle management of training courses (creation, review, approval, retirement).
  • Support version upgrades and continuous improvement of MasterControl, including configuration and testing.
  • Train users on MasterControl roles.
  • Support resolving system-related issues and ensure records are processed according to procedures.
  • Troubleshoot and provide solutions for challenges in the MasterControl EQMS.
  • Prepare quality metrics and reports.
  • Provide staff support regarding quality systems, including maintenance of logs, facilitating timely closure of records, and providing QA review.
  • Facilitate the document change request process, including formatting assistance, coordinating review/approval, and tracking documents.
  • Manage the Document Control room, ensuring data integrity and inspection readiness.
  • Maintain electronic and hardcopy history files of controlled documents.
  • Initiate updates and creation of new SOPs.
  • Copy, scan, and distribute controlled documents.
  • Issue, track, and/or reconcile controlled test record forms, logbooks, and laboratory notebooks.

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