QC Analyst 3
On-site · Winston-Salem, North Carolina, United States
Job Summary
QC Analyst 3 will support the quality control department by managing the analytical method lifecycle, including method transfer, validation, verification, and system qualification. Responsible for writing procedures, SOPs, and reports, monitoring method performance, data trending, and ensuring cGMP compliance. Will support ProKidney’s pipeline from Phase III through commercial operations, collaborate with cross-functional teams, and possess knowledge of FDA/EMA guidance and USP/EP compendial methods.
Required Qualifications
- Bachelor’s degree or equivalent in Chemistry/Biochemistry, or related discipline
- Minimum of 5 years of relevant professional experience in Quality Control, Analytical Development, or Microbiology
- 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
- 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
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
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