Quality Associate

We are seeking a detail-oriented and motivated Quality Associate to join our team. In this role, you will support the day-to-day operations of our Quality Assurance (QA) and facility compliance programs within a non-GLP, research-focused environment. You will work closely with the QA team and scientific staff to ensure scientific rigor, data integrity, and high-quality deliverables for our clients.

Key Responsibilities:

• 1. Document Control & Data Governance
• Lifecycle Management: Assist in the administration of the Document Control system, including the formatting, routing, and version control of policies and SOPs.
• Archiving: Manage the physical and digital QA archives. Ensure secure storage, accurate indexing, and controlled retrieval of raw data, completed study files, and logbooks.
• 2. Quality Management Systems
• Event Tracking: Assist in logging, tracking, and following up on Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls to ensure investigations and facility modifications are properly documented and resolved within timelines.
• Metrics Reporting: Periodically compile basic quality metrics (e.g., CAPA closure rates) to assist QA management in trend analysis.
• 3. Compliance, Audit & Vendor Support
• Audit Readiness: Support the preparation and hosting of external client audits (document retrieval, facility readiness) and participate in routine internal audits.
• Vendor Qualification: Maintain the Approved Vendor List (AVL), track vendor qualification statuses, and assist in renewing quality agreements.
• Client Inquiries: Assist in completing client quality questionnaires and ensuring sponsor expectations are met.
• 4. Operations & Facility Oversight
• Equipment & Training: Track laboratory equipment calibration/PM schedules and maintain personnel training matrices, ensuring scientists are up-to-date on required SOPs.
• Sample Management & EHS: Monitor the receipt, storage, and dispensation of Test Articles (TA) to ensure chain of custody. Support routine EHS walk-throughs to maintain a safe laboratory environment.