QC Chemist – Analytical Methods & Transfer

About the role

We are seeking a QC Chemist to support analytical method transfer, validation and verification within a GMP‑compliant laboratory. The role contributes to ensuring product quality and regulatory compliance through accurate testing and continuous improvement.

Key responsibilities

• Perform analytical method transfer, validation, verification and equivalency studies following SOPs, ALCOA principles and data‑integrity requirements.
• Execute analytical testing in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Apply the Imex way of working for daily operations, problem solving, escalation and continuous improvement.
• Participate in 5S initiatives and maintain good housekeeping and safety procedures.
• Assess product impact from compendial monograph changes and support regulatory submissions.
• Write and review SOPs and On‑the‑Job Training (OJT) documents.
• Conduct laboratory investigations, propose CAPA and handle QTS/eQMS actions, including change controls with GMP impact.
• Review and approve test results, and author position papers, protocols, reports and test procedures.
• Facilitate method transfer meetings with donating sites and train QC colleagues on new methods.
• Contribute to continuous‑improvement projects and Tier process performance tracking.
• Develop and validate cleaning methods and ensure documentation follows site GDP practices.

Required profile

• Bachelor’s degree with at least two years of relevant experience, or an Associate’s degree with four years, or a high‑school diploma with six years of experience.
• Demonstrated experience in method transfer, validation, verification and analytical testing.

Required skills

• Analytical method transfer
• Method validation and verification
• Method equivalency studies
• Good Manufacturing Practices (GMP)
• Good Laboratory Practices (GLP)
• Data integrity (ALCOA) principles
• SOP and OJT development
• Laboratory investigations and CAPA
• QTS/eQMS handling and change control
• Cleaning method development and validation
• Documentation and record‑keeping in a regulated environment