Validation & Quality Assurance Consultant; GMP

Overview

Role:
Validation & Quality Assurance Consultant (GMP)

Location: Boston, MA (Onsite – Monday to Friday)

Employment Type: Contract

Status: Accepting Candidates

We are seeking a Quality Engineering and Validation Consultant to support GMP operations and capital projects within a cutting-edge life sciences environment. This role focuses on maintaining high-quality standards, supporting validation efforts, and driving continuous improvement through effective quality systems and risk-based decision-making.

• Provide QA oversight and support for GMP manufacturing operations and capital projects.
• Support validation activities, including protocol review and execution.
• Lead and support event investigations, root cause analysis, and CAPA implementation.
• Review and manage change controls, deviations, and risk assessments.
• Ensure compliance with GMP standards across manufacturing, laboratory, and engineering functions.
• Provide quality oversight for equipment, facilities, utilities, and calibration programs.
• Support environmental monitoring (EM) and routine testing programs.
• Collaborate cross-functionally to resolve quality issues and ensure timely project delivery.
• Utilize systems such as Veeva, Nuvolo, and Viewlinc for quality and compliance activities.

• Experience providing QA support and oversight of GMP manufacturing operations and capital projects.
• Hands-on experience with aseptic processing.
• Strong experience in investigations, Root Cause Analysis, and CAPA management.
• Familiarity with systems such as Veeva, Nuvolo, and Viewlinc.
• Master’s degree with 3–5 years of relevant experience, OR Bachelor’s degree in engineering, scientific, or related field with 8+ years of experience.
• Strong understanding of GMP, GxP, and quality systems in pharma/biotech environments.

• Estimated hourly range: $60–$65/hr (W-2)
• Final rate will be determined based on experience and interview outcomes