Quality Assurance Validation

Help bring life-changing cell therapies from clinical trials to commercialization. As a QA Validation Contractor, you will champion compliance and data integrity across equipment, computerized systems, and facility operations in a fast-paced cGMP environment. Partner across Manufacturing, QC, Cytogenomics, and Materials Management to ensure strict FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 alignment, delivering high-quality standards and direct value to patients.

Location: Westborough, Massachusetts
Job type: Contract

Responsibilities

• Author, execute, and review validation protocols (IOPQ), URS, RASC, FS, CS, Traceability Matrices, and risk assessments.
• Validate equipment, computerized systems, and lab instrumentation, including controlled temperature units.
• Lead data integrity initiatives, periodic reviews, and vendor qualification package evaluations.
• Partner with IT, Facilities Engineering, Manufacturing, QC, and Lab teams on deviations, root cause analyses, and CAPAs.

Requirements

• Required Experience supporting biologics, cell therapy and/or gene therapy in a GxP environment.
• Demonstrated knowledge of GAMP 5 principles and 21CFRpart11/EU Annex 11 regulations.
• Experience with creating and reviewing validation lifecycle documentation for laboratory benchtop instruments with computerized systems.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.
• Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
• Solid technical writing skills with ability to document work in a meticulous and accurate manner.
• Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.

Qualifications

• Preferred BS/BA in Life Sciences, Engineering, or Chemistry with 1-3+ years of GMP validation experience (or 5+ years of relevant biotech/pharma industry experience).
• Experience with an electronic document management system.
• Experience with data acquisition software, such as KAYE Validator and Ellab ValSuite dataloggers used to perform mapping studies.

Pay

$45.00 - 56.29 per hour

Schedule

9 to 5

Benefits

• Medical, prescription, dental, and vision insurance offerings
• AD&D and life insurance
• Short-term disability
• 401K plan