QC Validation Chemist

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.

Requirements

• MINIMUM JOB QUALIFICATIONS
• Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Minimum 2+ years of laboratory experience in a regulated environment preferred.
• Demonstrated experience with analytical method validation, method verification, and laboratory investigations preferred.
• Experience working in a regulated laboratory environment.
• Strong understanding of analytical chemistry principles and laboratory investigations.
• Proficiency with Microsoft Office applications.
• PREFERRED JOB QUALIFICATIONS
• Advanced degree in Chemistry or related scientific discipline.
• Experience supporting ISO/IEC 17025 accredited laboratories.
• Experience in pharmaceutical, nutraceutical, dietary supplement, cannabis, food, or biotechnology industries.
• Experience implementing new analytical technologies and instrumentation.
• Experience with laboratory information management systems (LIMS).
• Experience of participating in regulatory inspections and accreditation audits.
• KNOWLEDGE, SKILLS, AND ABILITIES
• Technical Knowledge
• Strong working knowledge of: HPLC, GC, ICP-MS HPTLC, UV/VIS and Method Validation and Verification Principles
• Familiarity with: ISO/IEC 17025, cGMP Requirements, USP, AOAC, ICH Guidelines
• Skills And Competencies
• Strong understanding of analytical laboratory practices and quality systems.
• Knowledge of OOS investigations, CAPA processes, and data integrity principles.
• Excellent documentation, organizational, and problem-solving skills.
• Ability to manage multiple projects and priorities simultaneously.
• Effective verbal and written communication skills.
• Proficiency with laboratory software, LIMS, and Microsoft Office applications.
• OTHER ESSENTIAL JOB DUTIES AND 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-of-Trend (OOT), deviations, and non-conformances.
• Assist with root cause analysis and the development of effective corrective actions.
• Contribute to continuous improvement initiatives aimed at enhancing laboratory efficiency, compliance, and data quality.
• Identify opportunities to improve processes, procedures, and systems within the laboratory.
• Investigations and Root Cause Analysis
• Lead technical assessments associated with Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, and laboratory investigations.
• Support root cause investigations and corrective and preventive action (CAPA) development.
• Assist in evaluating analytical data and method performance to identify recurring trends and improvement opportunities.
• Audit and Accreditation Support
• Assist with preparation for internal audits, external audits, customer audits, and accreditation assessments.
• Support responses to audit findings and implementation of corrective actions.
• Participate in activities required to maintain laboratory accreditation and compliance status.
• Operational Support
• Provide technical and operational support to the Quality Control Compliance Team as needed.
• Collaborate with cross-functional departments to ensure timely completion of compliance-related projects and objectives.
• Support training initiatives related to compliance, data integrity, and laboratory quality systems.
• KEY PERFORMANCE INDICATORS
• Timely completion of validation and verification studies.
• Reduction of validation backlog.
• Timely closure of OOS investigations and CAPAs.
• Audit readiness and compliance performance.
• Data integrity compliance and documentation accuracy.
• Support of continuous improvement and accreditation objectives.
• WORK ENVIRONMENT
• Work is performed primarily in a smoke-free laboratory and office environment.
• Exposure to chemicals, laboratory equipment, and production areas may occur.
• Appropriate personal protective equipment (PPE) must be worn when required.
• We pride ourselves on maintaining a clean and organized environment, fostering a sense of pride and ownership in our space.
• Our culture is rich in diversity, quality, safety, fun, and respect, creating a vibrant and inclusive atmosphere.
• We are dedicated to professionalism and growth, continually striving to improve and excel in all we do.
• PHYSICAL REQUIREMENTS
• Frequent sitting, standing, walking, and use of laboratory equipment.
• Ability to lift and carry up to 25 pounds.
• Ability to perform repetitive hand and arm movements associated with laboratory testing.
• Ability to frequently stand and walk throughout office, manufacturing, and warehouse environments.
• Ability to occasionally bend, reach, stoop, and climb.