QC Analyst 3 in Winston-Salem, North Carolina at PROKIDNEY

Position Summary
The QC Analyst 3 will support various duties within the Quality Control (QC) department. This position plays a key role in ensuring the technical operations of QC, focusing on the technical suitability of bioanalytical test methods rather than day-to-day product testing. The role includes responsibility for the analytical method lifecycle, including method transfer, validation, compendial verification, performance monitoring, and continuous improvement, as well as ensuring analytical equipment is installed and qualified. The QC Analyst will support ProKidneys pipeline, from Phase III clinical development through commercial operations.

Responsibilities

Writes and executes procedures for analytical method protocols, generating reports related to QC method transfer, validation, and verification.
May write standard operating procedures (SOPs), protocols, and/or participate in instrument qualifications and analytical system validation.
Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements.
Assist with data trending and aid in compilation of trend reports utilizing statistical tools.
Work with internal departments to ensure system lifecycle document readiness and support analytical instrument qualification and system validation.
Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
Familiarity with FDA and EMA guidance documents relevant to cell therapy, and compendial methods from USP and EP.
Working knowledge of quality systems requirements.
Ability to work in a fast-paced, collaborative environment, managing workload based on changing priorities.
Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
Establish, revise, review, perform gap-assessment, and maintain procedures (including protocols and technical reports).
Assure laboratory procedures are compliant with current requirements and facilitate updates as needed.
Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
Maintain QC lab and related systems to ensure compliance with industry standards and inspection readiness.
Support CAPAs, deviations, investigations, and OOSs, ensuring effective resolution and continuous improvement.
Other tasks as assigned.

Qualifications

Bachelors degree or equivalent in Chemistry/Biochemistry, or a related discipline.
Minimum of 5 years of relevant professional experience, including a combination of Quality Control, Analytical Development, or Microbiology. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed.
Troubleshoot equipment and analytical testing methods.
Prior experience with analytical method validations.
Excellent technical writing skills.
Familiar with ICH quality guidelines and their application in QC laboratory environments.
Thorough understanding of industry testing requirements/standards.
Excellent time management skills; organized and able to meet company deadlines.
Ability to work and prioritize under pressure in an international environment.
Familiar with FDA and EMA guidance documents relevant to gene therapy.
Experience with Analytical Instrument Qualification and System Validation in laboratory environments.
Familiarity with compendial methods including USP and EP.