QA Manager, Document Control (Contract)
About The Position
Adverum Biotechnologies, Inc., a subsidiary of Eli Lilly and Company, is a clinical-stage company focused on developing gene therapy for prevalent ocular diseases. They aim to establish gene therapy as a standard of care, offering functional cures to restore vision and prevent blindness. Adverum utilizes a proprietary intravitreal (IVT) platform to develop single-administration therapies delivered in physicians’ offices, aiming to eliminate the need for frequent ocular injections. The company seeks to transform the standard of care for debilitating ocular diseases, preserve vision, and create a significant societal impact. This role is for a QA Manager, Document Control, reporting to the Sr. QA Manager, Master Control Project Administrator. The position involves performing duties essential to the maintenance and support of Document Control and Adverum’s quality systems, including System Administration of MasterControl EQMS, training, deviations, CAPAs, Change Control, Lot Disposition, Product Complaints, and other assigned duties within the QA department.
Requirements
- Minimum of a bachelor’s degree in a Life Science preferred or other relevant discipline.
- 7+ years of work experience with 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 is required.
- Must be able 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
- Assisting with system administration of MasterControl EQMS.
- Lifecycle management of controlled documents including creation, review, approval, and retirement per the internal QMS and SOPs.
- Lifecycle management of training courses including creation, review, approval, and retirement.
- Support version upgrades and continuous improvement efforts of MasterControl, including configuration and testing of new modules.
- Train current users and new users on MasterControl roles.
- Support resolving system related issues, and ensuring records are processed according to procedures and guidelines.
- Troubleshoot and provide solutions to challenges in the MasterControl EQMS.
- Prepare quality metrics and report.
- Provide staff support regarding quality systems, including maintenance of logs, facilitating timely closure of records and providing QA review as appropriate.
- Facilitate the document change request process, including providing formatting assistance, coordinating the review/approval process, tracking and routing of controlled documents.
- Manage the Document Control room, ensuring data integrity and inspection readiness.
- Maintain electronic and hardcopy history files of controlled documents, ensuring accurate and reliable filing systems.
- Initiates updates and creation of new SOPs as required.
- Copy, scan, and distribute controlled documents as needed.
- Issue, track and/or reconcile controlled test record forms, logbooks and laboratory notebooks.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
