QC Validation Chemist

ProCaps Laboratories, Inc.; Henderson (NV); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Medical, Dental & Vision

401(k) with company match

Life insurance

Short-term disability

Gym membership

Health Savings Account

Employee referral program

Inclusive work environment

Job summary

ProCaps Laboratories, Inc. is seeking a Validation Chemist to lead analytical method validation, verification, and compliance programs.

The role collaborates with QA and QC to ensure clean data, regulatory readiness, and continuous improvement of analytical processes. The ideal candidate will have a chemistry background, 2+ years in regulated labs, and hands-on experience with method validation, data integrity, and CAPA.

Qualifications

• Bachelor's degree in chemistry or related science.
• 2+ years of lab experience in a regulated environment preferred.
• Experience with analytical method validation and verification preferred.
• Experience in regulated lab environments and data integrity emphasis.

Responsibilities

• Execute analytical method validation and verification studies per protocols.
• Review validation results for compliance with quality standards.
• Support remediation of validation backlogs and CAPA actions.
• Assist in developing and updating validation protocols and reports.
• Maintain documentation following GDP and GMP-like expectations.

Skills

Validation & verification

Data integrity

CAPA processes

Documentation

Analytical reasoning

Cross-functional collaboration

Regulatory understanding

Laboratory problem-solving

Education

Bachelor's degree in Chemistry or related field

Advanced degree preferred

Tools

LIMS

Microsoft Office

HPLC

GC

ICP-MS

HPTLC

UV/Vis

Job description

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

Benefits

ProCaps provides :

• 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
• Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!