Compliance Specialist

Key Responsibilities

• Partner with Quality team members to support the end-to-end lifecycle of engineering documentation, ensuring required records and artifacts are created, reviewed, approved, finalized, and retained in accordance with established quality processes.
• Coordinate with contributors and cross-functional stakeholders to advance draft documentation, facilitate reviews, resolve outstanding actions, and obtain required approvals.
• Review documentation from a technical writing and documentation-quality perspective, identifying inconsistencies, gaps, or potential compliance concerns and escalating issues to the appropriate Quality team member.
• Maintain controlled documentation repositories and appropriate version-control practices, supporting traceability, document integrity, and audit readiness.
• Support compliance with internal policies and procedures related to risk, issue, and record management, including follow-up on outstanding or overdue documentation.
• Track documentation status, outstanding actions, approvals, and other deliverables and provide timely updates to Quality stakeholders.
• Manage document routing and administrative finalization, including uploads, version tracking, approval coordination, and sign-offs.
• Collaborate with Quality, Engineering, and other stakeholders to help ensure documentation is accurate, complete, appropriately controlled, and inspection-ready.

Qualifications

• Bachelor's degree in a scientific discipline required.
• Experience supporting Quality, Compliance, Engineering, or controlled documentation within a regulated environment strongly preferred.
• Experience in the pharmaceutical, biotechnology, life sciences, or other GxP-regulated industry preferred.
• Understanding of document lifecycle management, document control, version control, and approval workflows.
• Strong technical writing, proofreading, and documentation-review skills.
• Excellent organizational skills with the ability to manage multiple documents, deadlines, and stakeholders simultaneously.
• Strong attention to detail and ability to identify documentation inconsistencies or potential compliance issues.
• Effective written and verbal communication skills with the ability to work cross-functionally.
• Experience maintaining documentation in an electronic document management or quality management system is preferred.

Ideal Candidate