The Quality Assurance Engineer is a hands-on individual contributor within the Quality
Assurance organization at Recipharm Advanced Bio’s Watertown 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 is heavily focused on CAPA and Change Control program execution,
deviations and investigations support, as well as QA review and approval of protocols and
reports generated by cross-functional teams.
Reporting To: Senior Director, Quality & Regulatory (Watertown Site Quality Head)
Key Responsibilities
Quality Assurance & Quality Systems
CAPA Management
• Responsible for the CAPA program, ensuring timely closure and compliant processing
of CAPAs
• Host CAPA Review Board meetings to review CAPA status, progress, and timelines
• Lead cross-functional teams by managing all aspects of CAPA activities, including:
o Scheduling and facilitating meetings
o Ensuring appropriate root cause analysis techniques are applied
o Driving on-time closure of CAPAs
o Ensuring high-quality CAPA record content
o Supporting audit readiness and responding to CAPA-related audit questions
• Facilitate product and process CAPA investigations from issue identification through
implementation of corrective actions and effectiveness monitoring
• Analyze quality monitoring data and apply appropriate tools to identify existing and
potential causes of non-conformances
• Generate clear and transparent Quality KPI reporting and support continuous
improvement initiatives
Change Control Management
• Responsible for the Change Control program, ensuring timely closure and compliant
processing of changes
• Host Change Control Review Board meetings to review change status and
implementation progress
• Manage change requests and ensure changes are documented, reviewed, approved,
and implemented in a consistent and controlled manner
• Maintain the change control process, track progress, and coordinate with cross functional teams to ensure appropriate communication and implementation
• Maintain ongoing communication with stakeholders, including providing updates,
addressing questions or concerns, and escalating issues when needed
• Provide guidance to team members on proper use of the change control process
Deviations and Investigations
• Support deviation investigations and related documentation
• Provide QA guidance to cross-functional teams on documentation standards and
Quality System requirements
• Ensure QA oversight and compliance with site procedures, corporate quality standards,
and applicable regulatory requirements (e.g., cGMP)
• Drive timely closure of quality records while maintaining inspection-ready
documentation
• Contribute to other quality projects as assigned
Documentation & Technical Review
• Review and approve protocols and reports, including those related to:
o Technical transfer activities
o Quality Control (QC) laboratory investigations and method-related
documentation
o Manufacturing and process changes
• Author SOPs and other quality documentation, as applicable
• Ensure documentation is accurate, complete, and aligned with GMP expectations
Cross-Functional Partnership
• Act as a QA business partner to Manufacturing, QC, Technical Transfer, and
Operations teams
• Provide QA input during investigations, process changes, and tech transfer activities
• Support internal audits, regulatory inspections, and customer audits as needed
Required Qualifications
• B.S. or M.S. degree in a scientific field or related discipline
• Minimum 7 years of Quality Assurance experience in a regulated pharmaceutical,
biotech, or related GMP environment
• Strong hands-on experience with:
o CAPA management
o Change Control management
o Deviation and investigation write up, review, and support
• Strong understanding of Quality Systems and cGMP requirements
• Demonstrated ability to work independently, manage multiple priorities, and
exercise sound QA judgment
• Strong technical writing, document review, and communication skills
• High attention to detail, excellent organizational skills, and the ability to work on
multiple projects with tight deadlines
• Ability to proactively adapt to changing business priorities
Preferred Qualifications
• Strong understanding of CAPA and Change Control processes, root cause analysis,
and risk management
• Knowledge of applicable global GMP regulations and quality standards
• Experience providing QA support for technical transfer activities
• Prior experience in a CDMO environment (helpful but not required)
• Experience working in a growing or evolving manufacturing site
What Success Looks Like
• QA records (CAPAs, change controls, deviations) are thorough, compliant, and
closed on time
• QA support is consistent, practical, and respected by cross-functional partners
• Documentation is inspection-ready and aligned with site and regulatory
expectations
• The role operates independently, owning execution and follow-through within
defined Quality Systems
Salary Range: $110,000 – $145,000 per year