QA Validation Lead – GMP Compliance & Investigations

Neurotech Pharmaceuticals, Inc.; Cumberland (RI); On-site; USD 110,000 - 140,000; Full time

Job summary

Neurotech Pharmaceuticals, Inc., now part of Alconis, operates at Cumberland, RI, focusing on Encapsulated Cell Therapy for chronic eye diseases. The QA Operations Specialist, Validation, provides QA oversight of qualification and validation activities for equipment, facilities, utilities, systems, and processes, ensuring CGMP and GDP compliance.

You will collaborate with Validation, Manufacturing, QC, and other teams; mentor personnel on documentation; support change controls, deviations, and

Qualifications

• Bachelor’s degree in Science, Engineering, or related field with 5–7 years in QA/validation in GMP-regulated environment.
• Solid background in QA/Systems and/or Validation including regulations, guidelines, and compliance issues.
• Experience with quality review of qualification and validation documents.

Responsibilities

• Perform independent QA review and approval of qualification and validation documentation, including protocols, reports, discrepancies, requirements specifications, risk assessments, and supporting records.
• Ensure validation documentation complies with CGMP and GDP and is aligned with approved procedures.
• Provide QA oversight of qualification and validation lifecycle activities, including IQ/OQ/PQ, and assess changes or discrepancies that may impact the validated state.
• Collaborate with Validation, Mfg, QC, and other functions to support validation activities.
• Provide technical mentorship on qualification and validation documentation to Neurotech personnel.
• Support change controls by performing impact assessments for QA relevant to systems/equipment/facilities/utilities/processes changes.
• Ensure deviations are raised appropriately and support investigations related to systems/equipment/facilities/utilities/processes.
• Participate in Root Cause Analysis, CAPAs, and continuous improvement initiatives.
• Aid in identification of opportunities for process improvements.

Skills

Quality Assurance

Validation oversight

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in Science or Engineering

Tools

MS Office

Monday.com

Teams

Intellect

SAP

CMMS

MS Project

Job description

Neurotech Pharmaceuticals, Inc., now part of Alconis, operates at Cumberland, RI, focusing on Encapsulated Cell Therapy for chronic eye diseases. The QA Operations Specialist, Validation, provides QA oversight of qualification and validation activities for equipment, facilities, utilities, systems, and processes, ensuring CGMP and GDP compliance.

You will collaborate with Validation, Manufacturing, QC, and other teams; mentor personnel on documentation; support change controls, deviations, and