Quality Systems Analyst

Job Description

Job Summary:

• We are seeking an experienced Quality Systems Engineer contractor to support our GMP biotechnology operations.
• In this role, you will serve as a hands-on quality partner to Subject Matter Experts (SMEs) across manufacturing, laboratory, and technical functions.
• Your primary focus will be facilitating the timely and compliant completion of quality records — including change controls, deviations, laboratory investigations, and controlled document revisions — within our electronic Quality Management System (eQMS).

Duties and Responsibilities:

• Partner with SMEs to author, document, and route change control records in the eQMS.
• Assist operations and technical teams in opening, writing, and closing deviation records.
• Ensure change descriptions, impact assessments, and implementation plans are thorough, accurate, and compliant with GMP requirements.
• Track change control and deviation timelines and proactively follow up to prevent aging records.
• Collaborate with QC and analytical teams to support the documentation of Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
• Support SMEs in managing documents through the review, approval, and release workflow in the eQMS (e.g., Veeva Vault).
• Serve as a resource and coach for SMEs navigating quality processes and eQMS workflows.
• Identify and escalate quality issues or systemic trends to Quality management.
• Support audit readiness by ensuring quality records are complete, accurate, and on-time.
• Contribute to continuous improvement initiatives within the Quality Systems function.

Quals–

The ideal candidate brings strong working knowledge of GMP regulations, excellent writing and communication skills, and the ability to guide non-quality personnel through complex quality processes efficiently and without unnecessary burden.