QC Validation Chemist

ProCaps Labs • Henderson, NV

3d • Onsite

About The Position

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

• Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Experience working in a regulated laboratory environment.
• Strong understanding of analytical chemistry principles and laboratory investigations.
• Proficiency with Microsoft Office applications.
• 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
• 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.

Nice To Haves

• Minimum 2+ years of laboratory experience in a regulated environment preferred.
• Demonstrated experience with analytical method validation, method verification, and laboratory investigations preferred.
• 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.

Responsibilities

• 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.
• 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).
• 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.
• 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.
• 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.
• 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.

Benefits

• A competitive salary!
• Top-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program!
• Paid Time Off, Eight (8) Company Holidays
• 401(k) with Company Match – up to 4.5%
• 100% Company Life Coverage
• 100% Short Term Disability Coverage
• Gym Membership Reimbursement
• Vitamin Allowance + Discounts
• Company-Funded Health Savings Account ($1,600/year)
• Cash Reward Employee Referral Program
• Pet Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level