The QA Operations Specialist, Validation, is responsible for providing Quality Assurance oversight, review, and approval of qualification and validation activities associated with equipment, facilities, utilities, systems, and manufacturing processes at the Cumberland, RI site.
- 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 NT’s approved validation procedures and in accordance with CGMP and GDP.
- 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 functional areas to support validation activities.
- Provide technical mentorship and guidance to Neurotech personnel on qualification and validation documentation.
- Bachelor's degree in Science
- Engineering
- related discipline
