Adverum Biotechnologies, Inc.
Quality Assurance
QAManager,DocumentControl(Contract)
“QA Manager, Document Control (Contract) at Adverum Biotechnologies, Inc.. Skills: System Administration of MasterControl EQMS, Lifecycle management of controlled documents, Lifecycle management of training courses, version upgrades and continuous improvement efforts of MasterControl, configuration and testing of new modules, resolving system related issues, records are processed according to procedures and guidelines, Troubleshoot and provide solutions to challenges in the MasterControl EQMS, qu”
What You'll Achieve.
ensuring records are processed according to procedures and guidelines; data integrity; inspection readiness; accurate and reliable filing systems
Industry & Context.
critical thinking; problem-solving; Troubleshoot and provide solutions to challenges in the MasterControl EQMS
What They're Looking For.
Must Have
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, critical thinking, problem-solving, exceptional attention to detail, Ability to manage and prioritize multiple projects/tasks, with minimal supervision, and adapt to changing priorities
Nice to Have
bachelor’s degree in a Life Science
What You'll Do.
Assisting with system administration of MasterControl EQMS
Lifecycle management of controlled documents including creation
and retirement per the internal QMS and SOPs
Lifecycle management of training courses including creation
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
and distribute controlled documents as needed
track and/or reconcile controlled test record forms
logbooks and laboratory notebooks
How You'll Work.
Team & Collaboration
communicate well with all levels of staff
Communication Scope
communicate well with all levels of staff
Process & Methodology
Ability to manage and prioritize multiple projects/tasks
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