QC Validation Chemist

About the role

The Validation Chemist is responsible for executing validation, verification, and compliance-related activities to ensure laboratory operations meet regulatory, accreditation, and internal quality requirements. This role supports method lifecycle management, data integrity initiatives, investigation activities, audit readiness, and continuous improvement projects. The Validation Chemist works closely with Quality Control, Quality Assurance, and laboratory personnel to maintain compliance while improving efficiency and reliability of analytical processes. Work is performed primarily in a smoke-free laboratory and office environment, with potential exposure to chemicals, laboratory equipment, and production areas; appropriate PPE must be worn when required. The role requires frequent sitting, standing, walking, use of laboratory equipment, ability to lift up to 25 pounds, perform repetitive hand/arm movements, and occasional bending, reaching, stooping, and climbing.

Responsibilities

• Method Development and Validation: Execute analytical method validation and verification studies in accordance with approved protocols, applicable regulations, and internal procedures; review and document validation and verification results to ensure compliance with quality standards; support remediation efforts and reduction of validation backlogs through timely execution of assigned projects; assist in the development, revision, and implementation of validation protocols and reports.
• Compliance and Quality Systems: Perform compliance-related activities to support adherence to GMP, GLP, ISO, and applicable regulatory requirements; participate in data integrity reviews and assessments to ensure accuracy, completeness, consistency, and traceability of laboratory data; support implementation and monitoring of corrective and preventive actions (CAPA) resulting from investigations, audits, and compliance assessments; maintain accurate and complete documentation in accordance with Good Documentation Practices (GDP).
• Investigations and Continuous Improvement: Support laboratory investigations, including Out-of-Specification (OOS), Out