Quality Systems Analyst
Boston, New York, United States of America
Contract
2 hours ago
Key skills
Vault
About this role
We are looking for Quality Systems Analyst for our client in Boston, MA
Job Title: Quality Systems Analyst
Job Type: Contract
Job Overview:
Pay Range: $120hr - $125hr
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.