QA Compliance Associate

Work Location: Middlesex County, MA

Summary:

Seeking a quality compliance professional to support the review, investigation, and documentation of product quality complaints in a regulated manufacturing environment. This role ensures compliance with industry standards and internal procedures, working closely with quality leadership to maintain high standards of product integrity and documentation.

Responsibilities:

• Conduct evaluations and investigations of product quality complaints in collaboration with quality compliance leadership.
• Perform technical investigations to identify root causes of product quality issues.
• Document complaint assessments and investigation results using electronic quality management systems.
• Ensure all activities are compliant with cGMP, GDP, and relevant standard operating procedures.
• Assist with the management and resolution of CAPAs, deviations, and change controls as required.
• Support the preparation and review of quality documentation and reports.
• Participate in continuous improvement initiatives related to quality processes and systems.
• Contribute to additional quality-related tasks and projects as assigned by leadership.

Qualifications:

• Bachelor’s degree in a scientific discipline preferred.
• 3+ years of experience in a regulated pharmaceutical or medical device environment.
• Working knowledge of cGMP and Good Documentation Practices.
• Strong technical writing skills with the ability to clearly document investigations.
• Proficiency with Microsoft Word.
• Experience handling product quality complaints strongly preferred.
• Experience with electronic quality systems (such as TrackWise) is a plus.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
• Collaborative, service-oriented mindset.

Published Category: Quality & Validation