QC Scientist

Job Description

The QC Scientist will perform HPLC/UPLC testing on various samples, including In-Process DS release, DP release, DS stability, DP Stability, process validation, analytical method validation/transfer, method establishment/qualification, and non-routine samples. The role involves demonstrating proper laboratory safety and housekeeping practices through regular audits and inspections, ensuring all activities meet EHS requirements. Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods, including Reverse Phase, SEC, Titer concentration, and CEX.

Responsibilities

• Accurately record and report analysis results following lab procedures and quality systems.
• Recognize and report out-of-specification/out-of-trend results to laboratory management and recommend solutions.
• Maintain and troubleshoot analytical instrumentation and workspace as needed.
• Perform method validation and/or qualification testing as required.
• Author and/or review SOPs, test methods, forms, etc., in the document management system eDMS.
• Ensure compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Work with internal and external customers to ensure clear and open communication when resolving and raising issues.
• Collaborate with QC leads, PMs, and clients to maintain the health of client programs.

Essential Skills

• Minimum of 1 year of HPLC/UPLC experience in quality/analytical/pharmaceutical industry or similar experience.
• Proficiency in HPLC, GMP, chemistry, and EMPOWER.
• Knowledge of GMP regulations in a cGMP manufacturing environment.
• Working knowledge of scientific principles for a wide range of analytical techniques.