QC Analyst 3

Responsibilities

• Write and execute procedures for analytical method protocols, including reports for method transfer, validation, and verification
• Write SOPs and participate in instrument qualifications and analytical system validation
• Monitor analytical method performance and assess system suitability requirements
• Assist with data trending and compilation of trend reports using statistical tools
• Support analytical instrument qualification and system validation lifecycle documentation
• Present critical analytical issues and solutions to cross-functional teams
• Ensure laboratory procedures comply with current requirements and facilitate updates
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP)
• Support CAPAs, deviations, investigations, and OOSs to ensure continuous improvement

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related discipline
• Minimum of 5 years of professional experience in Quality Control, Analytical Development, or Microbiology
• Experience with analytical method validations and troubleshooting equipment
• Strong technical writing skills
• Familiarity with ICH quality guidelines, FDA, and EMA guidance documents
• Knowledge of compendial methods including USP and EP
• Experience with Analytical Instrument Qualification and System Validation
• Understanding of cGMP and quality systems requirements

About the Company

ProKidney is a biotechnology company supporting a pipeline from Phase III clinical development through commercial operations, focusing on cell therapy solutions.