Recipharm · 2 days ago
Senior Quality Assurance Engineer
Boston, MA
Contract
Onsite
Mid, Senior Level
$110K/yr - $145K/yr
7+ years expRecipharm is a leading Contract Development and Manufacturing Organisation (CDMO) providing manufacturing services of pharmaceuticals. The Quality Assurance Engineer role involves supporting the effective operation and continuous improvement of the Quality Management System, focusing on CAPA and Change Control program execution, deviations, investigations, and QA review of protocols and reports.
BiotechnologyManufacturingMedicalPharmaceutical
Responsibilities
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:
Scheduling and facilitating meetings
Ensuring appropriate root cause analysis techniques are applied
Driving on-time closure of CAPAs
Ensuring high-quality CAPA record content
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
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
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
Review and approve protocols and reports, including those related to:
Technical transfer activities
Quality Control (QC) laboratory investigations and method-related documentation
Manufacturing and process changes
Author SOPs and other quality documentation, as applicable
Ensure documentation is accurate, complete, and aligned with GMP expectations
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
Qualification
Required
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 CAPA management
Strong hands-on experience with Change Control management
Strong hands-on experience with 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
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
Company
Recipharm
Recipharm focused on supporting pharmaceutical companies in taking their products from early development to manufacturing.
5001-10000 employees
H1B Sponsorship
Recipharm has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$241.75MKey Investors
Bill & Melinda Gates Foundation
2025-01-13Grant
2016-01-27Post Ipo Equity· $32M
2014-09-19Post Ipo Debt· $209.75M
Leadership Team
Thomas Beck
Senior Vice President Quality Management
Magnus Renck
VP - Operations Development
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