Quality Assurance Associate – Control Coordinator

Job Title and Overview

Quality Assurance Associate – Change Control Coordinator. This role partners cross‑functionally with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance to support and oversee the site change management process, driving change controls, investigations, and quality system activities to timely closure in compliance with GMP and regulatory expectations.

• Coordinate and oversee daily activities within the site change management system.
• Lead or support Change Review Board (CRB) activities and facilitate cross‑functional collaboration.
• Drive change controls to closure in a timely and compliant manner.
• Communicate status updates and timelines across departments to support operational alignment.
• Support deviation investigations, including root cause analysis (RCA) and CAPA development.
• Provide technical review and guidance for quality documentation, investigations, and change controls.
• Write, revise, and maintain QA procedures and controlled documents.
• Support site quality metrics related to change management and identify trends as applicable.
• Participate in audits, inspection readiness activities, and continuous improvement initiatives.
• Manage QA projects independently with minimal oversight.
• Support a strong quality culture through coaching, collaboration, and technical guidance.

• Bachelor’s degree in a scientific discipline (preferred).
• 8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.).
• Strong expertise in change control and root cause analysis, with the ability to independently manage cross‑functional quality initiatives in a GMP‑regulated environment.

• 6+ years of experience with change control systems and RCA tools (5 Whys, Ishikawa/6M, etc.).
• Experience reviewing and approving GMP documentation, investigations, and change controls.
• Strong technical writing and communication skills.
• Experience with risk assessment tools and quality metrics reporting.
• Experience with electronic Quality Management Systems (eQMS).
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to manage multiple priorities with strong organizational skills.
• Experience working collaboratively across manufacturing and quality functions.
• Strong coaching and mentorship capabilities.

• Travel:
  Occasional