Analytical Method Development Lead – QC & Compliance

ProCaps Labs; Kentucky; On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Competitive salary

Medical coverage

401(k) with match

Life insurance

Job summary

ProCaps Labs in Kentucky seeks a Quality Control Method Development Specialist to lead analytical method development, validation, transfer, and investigations in support of cGMP and ISO/IEC 17025 accreditation.

You will be the SME for instruments including HPLC, GC, ICP-MS, UV/VIS, HPTLC, and Protein Analyzer, partnering with Quality Control Operations, Product Development, and QA to ensure methods are scientifically sound and fit for use.

Qualifications

• Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science.
• 3+ years of experience in analytical method development, validation, or laboratory quality control.
• Demonstrated experience with analytical method development and validation.
• Experience working in a regulated laboratory environment.
• Strong understanding of analytical chemistry principles and laboratory investigations.
• Proficiency with Microsoft Office applications.
• Strong working knowledge and experience in HPLC, GC, ICP-MS, UV/VIS, HPTLC or similar laboratory instrumentation
• Familiar with USP, AOAC, ICH, ISO/IEC 17025 and other analytical method development bodies

Responsibilities

• Develop, optimize, implement, and troubleshoot analytical methods for raw materials, in-process materials, finished products, stability programs, and new product formulations.
• Adapt USP, AOAC, customer, regulatory, and published methods for existing laboratory instrumentation and applications.
• Design and execute method validation, verification, transfer, equivalency, and performance studies.
• Prepare validation protocols, reports, technical assessments, and supporting documentation while maintaining validation master plans and roadmaps.
• Establish scientifically justified acceptance criteria and validation parameters.
• Lead the implementation, qualification, verification, and integration of new analytical instrumentation and technologies.
• Develop methodologies and procedures for emerging technologies, including HPTLC and Protein Analyzer platforms.
• Identify and implement opportunities to improve testing efficiency, accuracy, throughput, and automation.
• Serve as the laboratory subject matter expert for analytical methods, instrumentation, data interpretation, and technical troubleshooting.
• Provide technical support, training, competency development, mentoring, and problem-solving guidance to laboratory personnel.
• Lead technical assessments and investigations related to OOS, OOT, atypical results, and laboratory nonconformances.
• Support root cause analyses, CAPA development, analytical data reviews, trend evaluations, and continuous method improvement.
• Ensure method development, validation, and laboratory activities comply with ISO/IEC 17025, cGMP, data integrity, and applicable regulatory requirements.
• Support audits, accreditation assessments, regulatory inspections, internal audits, and maintain audit-ready documentation.
• Drive quality system improvements by reducing validation backlogs, improving laboratory performance metrics, enhancing method robustness and efficiency, supporting timely investigations, and contributing to continuous audit readiness and compliance.

Skills

Analytical method development

Laboratory investigations

Regulatory compliance

Education

Bachelor’s degree in chemistry or related science

Tools

HPLC

GC

ICP-MS

UV/VIS

HPTLC

Job description

ProCaps Labs in Kentucky seeks a Quality Control Method Development Specialist to lead analytical method development, validation, transfer, and investigations in support of cGMP and ISO/IEC 17025 accreditation.

You will be the SME for instruments including HPLC, GC, ICP-MS, UV/VIS, HPTLC, and Protein Analyzer, partnering with Quality Control Operations, Product Development, and QA to ensure methods are scientifically sound and fit for use.