QC Chemistry Lead

16h16 hours ago

Laboratoire Guerbet

Raleigh, US · Full-time · $110,000 – $140,000

About this role

At Guerbet, we build lasting relationships to enable people to live better. This is our Purpose as a global leader in medical imaging with pharmaceuticals, devices, digital and AI solutions. The QC Chemistry Lead at the Raleigh facility oversees analytical testing and quality assurance in the chemistry lab, ensuring cGMP, ICH, and regulatory compliance while leading a team of chemists.

Oversee testing of raw materials, in-process samples, finished drug substances, and stability studies to maintain product quality. Implement quality control procedures compliant with FDA, EMA, and other agencies. Conduct investigations into out-of-specification results and deviations, implementing corrective and preventive actions.

Collaborate with quality assurance, manufacturing, and regulatory affairs teams to support product development and release. Maintain and troubleshoot laboratory instruments like HPLC, FTIR, and UV-Vis Spectrophotometers. Lead audits, inspections, and provide training on analytical techniques and compliance standards.

Join a multicultural team of 2,600 people across more than 20 countries, playing a unique role in medical imaging's future. Practice values of Achieve, Cooperate, Care, and Innovate daily. Support continuous improvement, method transfers, validations, and new equipment implementation.

Requirements

Knowledge of cGMP, ICH guidelines, FDA, EMA regulatory standards
Proficiency in analytical testing with HPLC, FTIR, UV-Vis Spectrophotometers
Experience conducting OOS investigations, deviations, and CAPA processes
Familiarity with USP/EP/JP pharmacopeias, SOPs, and internal specifications
Skills in method transfers, validations, and verifications
Ability to ensure data integrity and GLP compliance
Leadership in training, mentoring, and evaluating lab analysts

Responsibilities

Lead, support, and mentor a team of QC chemists, ensuring adherence to laboratory protocols and regulatory requirements
Oversee the testing of raw materials, in-process samples, finished drug substances, and stability studies
Implement and maintain quality control procedures to ensure compliance with FDA, EMA, and other regulatory agencies
Conduct investigations into out-of-specification (OOS) results and deviations (EXC), implementing corrective and preventive actions (CAPA)
Ensure proper documentation and data integrity in accordance with Good Laboratory Practices (GLP)
Collaborate with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs
Maintain and troubleshoot laboratory instruments such as HPLC, FTIR, UV-Vis Spectrophotometers
Lead audits and inspections, ensuring readiness for regulatory reviews and provide training to QC staff