QC Analyst I

QC Analyst

Location : 46 Galli Drive, Novato, CA 94949

Schedule : 4x10 Dayshift | Sunday-Wednesday, 7 : 00 AM - 6 : 00 PM

Pay : $25-27 / hour

(Shifts may vary depending on business needs. Other schedules include Sunday-Wednesday Swing (1 : 00 PM - 12 : 00 AM) or Wednesday-Saturday Day / Swing.)

About the Role

The Quality Control Analytical In-Process (QCA-IP) Analyst plays a key role in supporting the production of high-quality therapeutics by performing analytical testing on in-process intermediates and drug products in compliance with current Good Manufacturing Practices (cGMP) . This position requires strong technical skills, attention to detail, and a proactive approach to problem-solving in a fast-paced laboratory environment.

You'll perform a variety of biochemical and analytical assays, ensure timely testing and reporting, and contribute to maintaining inspection readiness in support of commercial and clinical manufacturing operations.

Key Responsibilities

• Receive, log, and process in-process samples to maintain testing flow and compliance with best practices.
• Perform analytical assays including but not limited to : Protein determination (A280, Bradford, UV Absorbance), Enzyme activity, HPLC / UPLC , and method validation activities.
• Evaluate assay validity, calculate and summarize data, and report results within required timelines.
• Participate in method validation , investigations , technical studies , and method transfers .
• Support laboratory maintenance activities, reagent preparation, and supply inventory management.
• Identify and report deviations from laboratory procedures; assist with investigations as needed.
• Serve as a trainer for specific methods and provide guidance to less experienced staff.
• Contribute to continuous improvement initiatives and laboratory process optimization.
• Communicate effectively with team members, attend meetings, and actively participate in discussions.

Qualifications