Quality System Specialist
Position Summary
The Quality Systems Specialist supports Quality Systems operations through the administration and coordination of document control and change control activities. This role is responsible for routing controlled documents through established approval workflows, maintaining document records, supporting change control processes, and helping ensure documentation complies with applicable quality standards, procedures, and regulatory requirements. The specialist works closely with document authors, business process owners, Quality, Operations, Training, and other stakeholders to facilitate timely review, approval, implementation, and archival of quality documents and change records.
Key Responsibilities
Document Control Administration: Manage the end-to-end routing of controlled documents through established review and approval workflows. Coordinate document reviews with subject matter experts, process owners, and approvers. Monitor document status and follow up with stakeholders to support adherence to approval timelines. Review document submissions for completeness, formatting, version control, and procedural requirements. Maintain document control records and support accurate document lifecycle management. Assist document authors with templates, formatting standards, and document management best practices.
Support Change Control: Facilitate administrative activities associated with change control records within the electronic Quality Management System (eQMS). Review change requests for completeness and required supporting documentation before workflow progression. Route change controls through required review and approval paths. Track approvals, implementation activities, action items, and closure milestones. Monitor change control progress and communicate status updates to stakeholders. Support Change Review Board or similar governance meetings by preparing materials, documenting minutes, and tracking actions. Confirm associated document updates are appropriately linked to approved change records.
Qualifications
Education: Associate degree required; bachelor's degree preferred in Quality, Life Sciences, Business Administration, or a related field.
Experience: 5+ years of experience in document control, quality systems, records management, and change control within a regulated pharmaceutical, biotechnology, medical device, or similar environment.
Skills: Strong hands-on experience with Veeva Vault QualityDocs and other EDMS/eQMS platforms (TrackWise, MasterControl, SharePoint, or similar). Extensive experience coordinating change controls and cross-functional document approval workflows. Demonstrated ownership of GMP-controlled documentation and records management processes. Strong attention to detail, organization, and follow-through. Ability to manage multiple priorities and deadlines simultaneously. Strong knowledge of document control principles, records management practices, change control processes, and quality system requirements. Understanding of Good Documentation Practices and regulated quality environments. Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams. Strong written and verbal communication skills. Ability to collaborate effectively across functional areas and appropriately escalate issues.
Knowledge and Skills
Strong attention to detail, organization, and follow-through.
Ability to manage multiple priorities and deadlines simultaneously.
Strong knowledge of document control principles, records management practices, change control processes, and quality system requirements.
Understanding of Good Documentation Practices and regulated quality environments.
Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.
Strong written and verbal communication skills.
Ability to collaborate effectively across functional areas and appropriately escalate issues.
Preferred Systems Experience
Experience with additional document and quality management platforms such as TrackWise, MasterControl, SharePoint, or similar EDMS/eQMS systems.