Quality Control Method Development Specialist

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

The Quality Control Method Development Specialist is responsible for providing technical leadership for analytical method development, optimization, validation, verification, and transfer activities in support of ISO/IEC 17025 accreditation requirements, cGMP compliance, and laboratory quality system objectives. This position serves as the laboratory subject matter expert for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, Protein Analyzer, and other laboratory technologies.

The Method Development Specialist supports implementation of new analytical technologies, leads technical aspects of laboratory investigations, develops and executes validation protocols, and collaborates with Quality Control Operations, Product Development, Quality Assurance, and other stakeholders to ensure analytical methods are scientifically sound, compliant, and fit for intended use.

This role is a key member of the Quality Control Compliance Team and plays a critical role in maintaining accreditation, reducing validation backlogs, improving data quality, and supporting continuous improvement initiatives.

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS

• 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

OTHER ESSENTIAL JOB DUTIES AND 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.

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.

PHYSICAL REQUIREMENTS

• Frequent sitting, standing, walking, and climbing
• Able to lift up to 25 lbs.

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!