Our client, a leading Life Sciences company, is hiring a Senior Quality Assurance Engineer.

Work Location: Middlesex County, Massachusetts

Summary:

The Quality Assurance Engineer is a hands-on individual contributor within the Quality Assurance organization at the site. This role supports the effective operation and continuous improvement of the site Quality Management System (QMS) and provides QA support across Manufacturing, QC, and Technical Transfer activities.
This position focuses on end-to-end ownership and management of the site CAPA and Change Control programs, including governance, follow-up, and on-time closure, as well as deviation and investigation support and QA review and approval of protocols and reports.

Responsibilities:

• Quality Assurance & Quality Systems CAPA Management
  • Own the site CAPA program end-to-end, including governance, prioritization, follow-up, escalation, and on-time closure
  • Host CAPA Review Board meetings to review CAPA status, progress, and timelines
  • Lead cross-functional CAPA activities, including scheduling meetings, ensuring appropriate root cause analysis, driving on-time closure, maintaining high-quality records, and supporting audit readiness
  • Facilitate product and process CAPA investigations through corrective action implementation and effectiveness monitoring
  • Analyze quality data to identify existing and potential non-conformances
  • Generate Quality KPIs and support continuous improvement initiatives
• Change Control Management
  • Own the site Change Control program, ensuring compliant execution, effective implementation, and on-time closure
  • Host Change Control Review Board meetings to review change status and implementation progress
  • Manage change requests to ensure changes are documented, reviewed, approved, and implemented in a controlled manner
  • Track change progress and coordinate with cross-functional teams to ensure timely communication and implementation
  • Provide guidance on proper use of the change control process
• Deviations and Investigations
  • Support deviation investigations and related documentation
  • Provide QA guidance on documentation standards and Quality System requirements
  • Ensure compliance with site procedures, corporate quality standards, and cGMP requirements
  • Drive timely closure of quality records while maintaining inspection-ready documentation
  • Support additional quality projects as needed
• Documentation & Technical Review
  • Review and approve protocols and reports related to technical transfer, QC investigations, and manufacturing or process changes
  • Author SOPs and other quality documentation as needed
  • Ensure documentation is accurate, complete, and GMP-compliant
• Cross-Functional Partnership
  • Act as a QA business partner to Manufacturing, QC, Technical Transfer, and Operations
  • Provide QA input during investigations, process changes, and tech transfer activities
  • Support internal audits, regulatory inspections, and customer audits

Qualifications:

• B.S. or M.S. degree in a scientific field or related discipline
• Minimum 7 years of QA experience in a regulated pharmaceutical, biotech, or GMP environment
• Hands-on experience owning and managing CAPA, Change Control, and deviation/investigation processes
• Strong understanding of Quality Systems and cGMP requirements
• Ability to work independently, manage priorities, and exercise sound QA judgment
• Strong technical writing, documentation review, and communication skills
• High attention to detail and ability to manage multiple deadlines
• Strong knowledge of CAPA, Change Control, root cause analysis, and risk management
• Knowledge of global GMP regulations and quality standards
• Experience supporting technical transfer activities
• Prior CDMO experience (helpful but not required)
• Experience working in a growing or evolving manufacturing site

Published Category: Quality & Validation