QC Analyst

Senior QC Analyst

Role Overview

Our client is seeking a Senior Quality Control (QC) Analyst. In this role, you will be primarily responsible for the advanced chromatographic and wet chemistry analysis of raw materials, in-process samples, finished products, and stability samples, ensuring full compliance with relevant GMP documentation and guidelines.

Key Responsibilities

• Analytical Testing: Conduct routine chromatographic (primarily HPLC, as well as GC) and wet chemistry testing on raw materials, in-process, finished, and stability samples in strict accordance with GLP and cGMP procedures.

• Method Transfer: Assist with the transfer, onboarding, and troubleshooting of analytical methods into the QC laboratory.

• Investigation Management: Coordinate and supervise laboratory investigations, ensuring they are accurately documented, actioned, and closed out efficiently. Escalate Out-of-Specification (OOS) results and initiate Field Alert Reports (FARs) within required timelines.

• Training & Mentorship: Support the development of the team by assisting with chromatography and wet chemistry training for other QC analysts.

• Data Review: Review and approve both chromatographic and non-chromatographic laboratory data.

• Audit Support: Act as a subject matter expert (SME) during regulatory and third-party inspections.

• Compliance & Documentation: Manage QC Standard Operating Procedures (SOPs), change controls, deviations, and Incident Report Forms (IRFs).

• Equipment Maintenance: Perform regular calibration and routine maintenance on wet chemistry and chromatography instrumentation.

• Continuous Improvement: Support laboratory continuous improvement initiatives, including 6S and Lean processes, alongside other projects assigned by leadership.

Skills & Experience Required

• Education: Minimum of a Bachelor's degree (or equivalent) in a science-related discipline (such as Chemistry, Biochemistry, or Analytical Science).

• Experience: 2+ years of relevant pharmaceutical or biotechnology industrial experience.

• Technical Skills: Essential experience in HPLC/GC and peptide analysis within a method validation or transfer environment. Proficiency with Empower software is highly preferred.

• Core Competencies: Strong working knowledge of chemistry/biochemistry techniques, solid technical writing skills, and a firm grasp of cGMP standards.

• Systems & Software: Experience using laboratory and operational software (e.g., Trackwise, LIMS, Minitab, MS Office).

• Problem Solving: Strong mathematical skills with the ability to solve practical, routine problems through standardized solutions and detailed procedures.