Quality Control Analyst III

Responsibilities

• Perform analytical testing of incoming raw materials, in-process samples, finished products, and stability samples using laboratory equipment such as balances, pipettes, pH meters, UV/Visible spectrophotometers, and Total Organic Carbon analyzers.
• Conduct chromatographic analysis including HPLC, GC, and UPLC with minimal supervision following established methods and procedures.
• Wet chemistry and analytical assays, including testing by HPLC, GC, IR, UV, and other analytical techniques.
• Support raw material testing and sampling in accordance with established quality procedures.
• Maintain general laboratory equipment, ensure proper laboratory housekeeping, and support preparation activities for internal and external audits.
• Perform or assist with method qualifications, method transfers, and validation activities within the QC laboratory.
• Assist with analytical method development initiatives.
• Support cleaning validation studies and related testing activities.
• Assist in the evaluation and implementation of new laboratory equipment and processes.
• Review QC data and provide summaries and reports to management as needed.
• Assist QC management with investigations related to OOS results, deviations, and CAPAs.
• Provide backup support for analytical sample receipt and logistics, including sample login, shipment to external labs, tracking, distribution of test results, and documentation closure.

Qualifications

• Bachelor’s degree in Chemistry or a related scientific discipline
• 3–5 years of experience in a pharmaceutical or regulated laboratory environment, or an equivalent combination of education and experience
• Preferred Qualifications: Experience working in a cGMP or GLP pharmaceutical environment, Hands-on experience with chromatographic techniques (HPLC, GC, UPLC) and analytical instrumentation, Experience supporting method validation, method transfer, or quality investigations