QC Specialist, Method Development and Validation As a QC Specialist, Method Development and Validation, you will serve as a technical leader and subject matter expert for analytical methodologies, instrumentation, and laboratory investigations. You will lead method development, validation, transfer, and lifecycle activities while partnering with Quality Assurance, Manufacturing, Regulatory Affairs, Process Development, Technical Operations, and external contract laboratories.
Key Responsibilities Analytical Method Development and Validation - Lead the development, optimization, qualification, validation, verification, and lifecycle management of analytical methods in accordance with ICH, USP, FDA, EMA, and applicable regulatory requirements.
- Design and execute scientifically sound method development studies for chemical, biochemical, and biological analyses.
- Author and review validation protocols, method transfer protocols, technical reports, qualification reports, and related documentation.
- Establish analytical acceptance criteria, method performance requirements, and system suitability parameters.
- Evaluate method robustness, accuracy, precision, linearity, specificity, range, detection limits, quantitation limits, and intermediate precision.
- Implement new analytical technologies and methodologies to improve laboratory performance and data quality.
- Lead analytical method troubleshooting, optimization, and continuous improvement initiatives.
- Manage method lifecycle activities, including periodic assessments, revisions, and retirements.
Technical Leadership and Scientific Expertise - Serve as the primary subject matter expert for designated analytical techniques, instrumentation platforms, and laboratory processes.
- Provide scientific guidance and technical leadership to analysts, specialists, and cross-functional teams.
- Lead complex laboratory investigations involving out-of-specification, out-of-trend, atypical results, and method performance issues.
- Assess the scientific impact of deviations, change controls, and CAPAs related to analytical methods and laboratory systems.
- Present technical findings and recommendations to management and cross-functional stakeholders.
Method Transfer and Validation Support - Lead analytical method transfers between internal laboratories, manufacturing sites, and external contract testing organizations.
- Evaluate transfer data and confirm successful demonstration of method performance at receiving laboratories.
- Collaborate with development and manufacturing teams to implement analytical methods throughout the product lifecycle.
- Support process validation, cleaning validation, stability programs, and comparability studies through analytical oversight and testing strategies.
Laboratory Operations and Compliance - Perform and oversee complex laboratory testing using validated analytical methods.
- Ensure compliance with cGMP, GLP, data integrity requirements, and company procedures.
- Review analytical test data, laboratory notebooks, electronic records, and reports for accuracy, completeness, and regulatory compliance.
- Support laboratory instrumentation through qualification, calibration, maintenance, and troubleshooting.
- Evaluate and implement technologies that improve efficiency, compliance, and data reliability.
- Monitor laboratory trends and recommend improvements to analytical practices and quality systems.
Documentation and Regulatory Support - Author and review SOPs, analytical methods, specifications, protocols, reports, and technical assessments.
- Prepare analytical sections of regulatory submissions and responses to regulatory agencies, as required.
- Ensure documentation complies with ALCOA+ principles and applicable data integrity requirements.
- Support document revisions and change-control activities associated with analytical methods and laboratory systems.
- Provide technical documentation and support for regulatory inspections and audits.
Training, Mentoring, Safety and Quality - Develop training materials and mentor laboratory personnel in analytical techniques, GMP compliance, and scientific best practices.
- Qualify and train analysts on analytical methods, instrumentation, and laboratory procedures.
- Provide technical coaching for method troubleshooting and investigation activities.
- Promote scientific excellence, continuous improvement, and compliance throughout the laboratory.
- Adhere to applicable health, safety, environmental, and quality requirements.
- Proactively identify risks and implement corrective actions to maintain a safe and compliant laboratory environment.
Expertise and Experience - Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline required.
- Master's degree or PhD preferred.
- Minimum of eight years of progressive experience in pharmaceutical, biotechnology, biologics, cell therapy, gene therapy, or a related GMP-regulated industry.
- Demonstrated experience in analytical method development, validation, verification, and transfer.
- Strong knowledge of ICH Q2(R2), USP, FDA, EMA, GMP, and data integrity requirements.
- Experience supporting regulatory inspections and audits preferred.
Technical Skills and Expertise - Expert knowledge of analytical method development, validation, qualification, and lifecycle management.
- Advanced experience with chromatographic, spectroscopic, and biological analytical techniques, including:
- Strong statistical knowledge related to method validation and data trending.
- Experience with laboratory software systems, chromatography data systems, LIMS, and electronic quality systems.
- Working knowledge of risk-assessment tools and quality-management systems.
Core Competencies - Scientific and technical leadership
- Critical thinking and problem solving
- Analytical investigation expertise
- Project management and prioritization
- Technical writing and documentation
- Cross-functional collaboration
- Regulatory compliance knowledge
- Strong verbal and written communication
- Results orientation and exceptional attention to detail
- Ability to influence technical decisions and drive continuous improvement
Working at Croda The successful candidate will receive a competitive salary and benefits package, including:
- Excellent Medical, Dental, and Vision coverage, available immediately
- Company-paid and voluntary Life and AD&D insurance
- Short- and long-term disability
Additional Information This is an on-site role located in Alabaster, Alabama.
If you require any reasonable adjustments during the hiring process or experience any issues with our online application process, please email [redacted].
