QC Chemistry Lead
On-siteRaleigh, North Carolina, United States
Job Summary
Lead, mentor and supervise a team of QC chemists in a cGMP-compliant pharmaceutical QA/QC laboratory at the Guerbet Raleigh Imaging manufacturing facility. Responsible for overseeing analytical testing across raw materials, in-process samples, finished drug substances, and stability studies; ensure testing and documentation meet FDA/EMA/USP/cGMP standards; investigate out-of-specification results and deviations with CAPA; maintain data integrity and GLP-compliant documentation; conduct audits and inspections readiness; train and develop staff; maintain instrumentation (HPLC, GC, UV-Vis, FTIR, etc.); participate in method transfers, validations, and regulatory/commercial product releases; collaborate with QA, manufacturing, and regulatory affairs to support product development and release; drive continuous improvement and ownership of laboratory quality systems.
Required Qualifications
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related discipline
- 5+ years of pharmaceutical QC laboratory experience
- 1–3 years in a leadership or senior analyst role preferred
- Proficiency with HPLC, GC, UV-Vis, FTIR
- Familiarity with LIMS, CDS ( Empower )
- Strong understanding of cGMP, FDA, ICH, and USP guidelines
- Knowledge of data integrity
- Auditing and corrective action proficiency
- Excellent communication and problem-solving skills
- Ability to lead a team in a fast-paced, regulated environment
- Experience with method transfers, validations, and verifications
- Laboratory safety practices
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