Overview
Quality Assurance Specialist Jobs in Boston, MA at Redbock – an NES Fircroft company
Title: Quality Assurance Specialist
Company: Redbock – an NES Fircroft company
Location: Boston, MA
Overview
We are seeking an experienced Quality Engineering & Validation Consultant to provide GMP Quality oversight in support of manufacturing operations, validation activities, and capital projects within a regulated biopharmaceutical environment. This individual will partner cross-functionally with Manufacturing, Engineering, Validation, Facilities, Materials Management, and Quality teams to ensure compliance with GMP requirements while supporting clinical and commercial operations.
This role is ideal for a hands-on Quality professional with strong validation, investigation, and CAPA experience who thrives in a fast-paced manufacturing environment.
Responsibilities
- Provide Quality oversight for GMP manufacturing operations, validation activities, and capital projects supporting clinical and commercial production.
- Review and approve quality documentation, including change controls, validation protocols, risk assessments, investigations, and CAPAs.
- Partner cross-functionally with Manufacturing, Engineering, Validation, Facilities, Laboratory Operations, and Materials Management to ensure GMP compliance.
- Support equipment, facility, and utility qualification activities, including calibration, preventive maintenance, work orders, and instrument qualification.
- Review and approve equipment, facility, and utility trending programs while identifying compliance risks and driving resolution of quality issues.
- Support environmental monitoring, facility control systems, and related quality programs to ensure inspection readiness and regulatory compliance.
- Apply risk-based decision making while identifying process improvements and communicating quality risks to project teams and leadership.
Qualifications
- BS degree in Engineering, Life Sciences, or a related technical discipline (Master's degree preferred).
- 8+ years of Quality Assurance experience supporting GMP manufacturing operations within the pharmaceutical, biotechnology, or cell & gene therapy industry.
- Experience providing Quality oversight for validation activities, engineering projects, and capital equipment.
- Strong experience leading or supporting GMP investigations, root cause analysis, CAPA, change controls, and risk assessments.
- Working knowledge of aseptic manufacturing and GMP regulations.
- Experience with electronic quality systems such as Veeva, Nuvolo, ViewLinc, or similar platforms.
- Excellent communication, collaboration, and problem-solving skills with the ability to work effectively across cross-functional teams.
Preferred Qualifications
- Experience supporting cell and gene therapy manufacturing.
- Experience working in both clinical and commercial manufacturing environments.
- Strong understanding of equipment qualification, facility validation, and utilities within GMP operations.
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