Recipharm · 7 hours 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 Senior Quality Assurance Engineer will support the effective operation and continuous improvement of the site Quality Management System, focusing on CAPA and Change Control programs, deviation investigations, and cross-functional partnerships.
BiotechnologyHealthcareManufacturingPharmaceuticalMedical
Responsibilities
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
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
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
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
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
Qualification
Required
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
Preferred
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
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
Magnus Renck
VP - Operations Development
Marc Funk
Board Member
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