Revance International - Newark, CA
posted 4 months ago
The Quality Control Analyst I, Analytical will be responsible for the testing of in-process, lot release, and stability samples for various commercial and clinical drug products. This role involves authoring and revising Standard Operating Procedures (SOPs), deviations, change requests (CRs), and laboratory investigation reports (LIRs). The analyst will conduct tests on samples for various parameters including Appearance, pH, UV and water content, as well as perform analytical techniques such as HPLC, ELISA, Western Blot, and SDS-PAGE as required. The position requires participation in or leading investigations, reporting, and process optimization activities, and necessitates active involvement in group and project teamwork. The Quality Control Analyst will perform routine and non-routine release, in-process, and stability testing for drug substances, drug products, and other critical reagents, ensuring compliance with current Good Manufacturing Practices (cGMP). The analyst will independently author and lead quality records such as deviations, lab investigations, corrective and preventive actions (CAPA), and change controls, ensuring thorough and timely investigations and implementation activities. Additionally, the analyst will support method development, optimization, transfer, qualification, and validation activities of analytical methods, and will be involved in equipment and software qualification and maintenance activities. The role also includes reviewing laboratory records generated in support of QC testing, providing training to laboratory analysts, and guiding junior analysts in the lab environment, including troubleshooting. The analyst will work on multiple projects to meet departmental and organizational goals and will collaborate with Manufacturing, Quality Assurance (QA), and Regulatory teams to support Chemistry, Manufacturing, and Controls (CMC) analytical deliverables.