QA Validation Lead — GMP & Compliance

Neurotech Pharmaceuticals, Inc.; Needham (MA); On-site; USD 100,000 - 115,000; Full time

Job summary

Neurotech Pharmaceuticals, Inc. in Cumberland, RI and Needham, MA, seeks a QA Operations Specialist to oversee qualification and validation activities across equipment, facilities, and processes.

The role partners with Validation, Manufacturing, and QC to ensure CGMP/GDP compliance and continuous quality improvements. The ideal candidate brings 5–7 years of QA experience in regulated environments and strong documentation review skills.

Qualifications

• Bachelor's degree in Science, Engineering, or related discipline.
• 5–7 years of QA experience in GMP-regulated environments.
• Experience with qualification and validation documentation.
• Knowledge of CGMP and GDP regulations.
• Ability to review and approve qualification/validation documentation.

Responsibilities

• Perform independent QA review and approval of qualification and validation documentation.
• Ensure validation documentation complies with CGMP and GDP.
• Provide QA oversight of IQ/OQ/PQ and evaluate changes.
• Collaborate with Validation, Manufacturing, QC to support validation activities.
• Provide technical mentorship on qualification/validation documentation and deviations.
• Support change controls and investigations related to quality systems.
• Lead deviation investigations and CAPA activities as needed.
• Identify continuous improvement opportunities in validation processes.

Skills

QA oversight

Validation lifecycle

CGMP/GDP knowledge

Documentation review

Risk assessment

Cross-functional collaboration

Mentorship

Investigation & CAPA

Education

Bachelor's degree in Science, Engineering, or related discipline

Tools

MS Office

SAP

CMMS

MS Project

Monday.com

Teams

Job description

Neurotech Pharmaceuticals, Inc. in Cumberland, RI and Needham, MA, seeks a QA Operations Specialist to oversee qualification and validation activities across equipment, facilities, and processes.

The role partners with Validation, Manufacturing, and QC to ensure CGMP/GDP compliance and continuous quality improvements. The ideal candidate brings 5–7 years of QA experience in regulated environments and strong documentation review skills.