QC Validation Analyst

• Provide technical expertise in the development, optimization, qualification, and validation of analytical methods to support product development, formulation studies, material release, and in-process monitoring.
• Design and execute method development and validation activities across multiple stages of product and process development.
• Develop, validate, transfer, and document analytical methods; generate and author validation protocols and final reports.
• Design validation studies in compliance with ICH and applicable regulatory guidelines, identifying critical method parameters beyond minimum requirements when necessary.
• Perform chemical and physical analyses on raw materials and finished products using standard analytical instrumentation, including HPLC, LC-MS, GC, GC-MS, MS, and ICP-MS.
• Review analytical data, laboratory notebooks, and results prior to data release; collect, analyze, and interpret data accurately.
• Review, author, and improve laboratory SOPs and forms to ensure clarity, compliance, and proper record retention.
• Support investigations, including Out-of-Specification (OOS) results, and guide appropriate re-testing strategies.
• Maintain analytical laboratory equipment through routine standardization, maintenance, and support of IQ/OQ/PQ and preventive maintenance activities.
• Support continuous improvement initiatives to enhance laboratory efficiency, quality, and compliance.
• Monitor laboratory inventory required for validation activities and prepare purchase requests as needed.
• Collect and maintain Safety Data Sheets (SDS) for chemicals and reagents.
• Write SOPs and train laboratory personnel on analytical methods and best practices.
• Participate in and support laboratory safety training programs.
• Operate laboratory equipment safely and in accordance with established procedures.
• Perform additional related duties as assigned.

• Bachelor's or Master's degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Biological Sciences, Bioengineering, or related field).

• Minimum of 5 years of experience in analytical assay development and optimization.
• Demonstrated experience in analytical method development, optimization, and validation.
• Hands-on experience with one of the following: LC-MS, GC, GC-MS, and ICP-MS is required.

Morgan McKinley