QC Scientist (HPLC Chemist)

Job Description Job Description Job Title: QC Scientist I Job Description The QC Scientist I performs a wide range of analytical testing using HPLC and UPLC in a GMP-regulated laboratory environment, supporting in-process and release testing, stability studies, process validation, and analytical method validation and transfer. This role ensures accurate, compliant generation of data for drug substance and drug product, contributes to method establishment and qualification, and supports both routine and non-routine testing activities. The position offers the opportunity to grow into a full-time role while working in a culture that emphasizes continuous learning, professional development, and meaningful contributions to healthcare. Responsibilities Perform HPLC and UPLC testing for in-process drug substance release, drug product release, drug substance stability, drug product stability, process validation, analytical method validation and transfer, method establishment and qualification, and various non-routine samples. Conduct GMP-compliant testing in an analytical laboratory environment using HPLC and UPLC test methods, including Reverse Phase, SEC, titer/concentration, and CEX assays. Accurately record, analyze, and report test results in accordance with established laboratory procedures and quality systems. Recognize out-of-specification and out-of-trend results, promptly report them to laboratory management, and recommend appropriate solutions or follow-up actions. Maintain, operate, and troubleshoot analytical instruments and associated laboratory equipment to ensure reliable performance and minimal downtime. Perform method validation and qualification testing as required to support new or existing analytical methods. Author and review standard operating procedures, test methods, forms, and related documentation within the electronic document management system (eDMS). Demonstrate proper laboratory safety and housekeeping practices, including participation in weekly 5S laboratory audits and monthly laboratory inspections, ensuring all activities meet EHS requirements. Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable safety guidelines. Work collaboratively with internal and external customers to maintain clear and open communication when raising, resolving, and following up on issues. Partner with QC leads, project managers, and clients to support the overall health and success of client programs. Contribute to a culture of continuous improvement in laboratory practices, documentation quality, and analytical workflows. Essential Skills 0-2 years of hands-on HPLC and UPLC experience in a quality, analytical, pharmaceutical, or closely related industry environment. Experience performing HPLC/UPLC assays, with familiarity in methods such as SEC, CEX, glycans, and peptide mapping considered a strong advantage. Working knowledge of GMP regulations and experience operating within a cGMP manufacturing or quality control environment. Foundational understanding of scientific principles underlying a wide range of analytical techniques in analytical chemistry and wet chemistry. Ability to follow and apply Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Standard Operating Procedures (SOPs), and safety guidelines in daily work. Strong attention to detail and accuracy in documenting, analyzing, and reporting laboratory data. Ability to identify out-of-specification and out-of-trend results and communicate findings clearly to laboratory management. Basic troubleshooting skills for analytical instruments and laboratory equipment. Effective communication skills for collaborating with QC leads, project managers, and external partners. Ability to work independently at the bench while adhering to established quality and safety standards. Additional Skills & Qualifications Prior experience with EMPOWER chromatography data software is preferred but not required. Experience with a variety of HPLC/UPLC assays, including SEC, CEX, glycans, and peptide mapping, is considered a plus. Background in quality control, analytical chemistry, and wet chemistry in a regulated environment. Strong working knowledge of scientific principles for a broad range of analytical techniques is strongly preferred. Interest in professional development and continuous learning within a high-performing scientific organization. Ability to contribute to and thrive in a culture that values innovation, R&D investment, and meaningful impact on global health. #J-18808-Ljbffr Actalent