Analytical Chemist II
hace 18 días
Costa Mesa
Job Description POSITION SUMMARY Under limited supervision, the Chemist II is responsible for performing routine analytical testing, method validation/transfer activities, preparing technical documentation, and maintaining laboratory equipment in the quality control analytical laboratory. RESPONSIBILITIES • Perform routine laboratory testing (i.e., HPLC, UV-Vis, FTIR, CE, KF Titration, INSTRON, osmolality, pH, color/clarity, CCIT, particulate matter, wet chemistry) including finished product release, stability studies, and raw materials, following SOPs and GMP requirements., • Assist with routine testing for WFI samples, including TOC, conductivity, and endotoxins, as needed., • With guidance, author and execute protocols for method transfer, qualification, and validation., • Create data summaries and author technical reports., • Develop and revise SOPs, as needed., • Train and guide junior chemists., • Perform QC peer-review of laboratory raw data for basic tests., • Calibrate, maintain, and troubleshoot various basic analytical instruments, such as osmometers, pH/conductivity meters, balances, plate readers, etc., • Calibrate, maintain, and troubleshoot various complex instruments such as HPLC, LC/MS, GC, UV/SoloVPE, etc., with guidance., • Initiate problem-solving for technical issues commensurate with level of experience., • Assist with the implementation of new equipment, instruments, and software., • Support quality system activities, such as deviation investigations and laboratory OOS/OOT investigations. QUALIFICATIONS AND EXPERIENCE • Bachelor’s or advanced degree in analytical chemistry, biochemistry, or a related field, • 4+ years (with Bachelor’s) or 2+ years (with advanced degree) of analytical quality control experience in a cGMP setting, covering early and late-phase products., • Hands-on experience with HPLC, UV-Vis, and other common analytical equipment and techniques., • Experience executing method validations and method transfers., • Proficiency with Microsoft Office and laboratory software for data collection and analysis. Experience with Chromeleon CDS is preferred., • Knowledge of ICH, USP, Ph. Eur., and other regulatory and quality guidelines preferred., • Effective communication skills, both written and verbal, for interaction with staff and vendors.