Sr. QC Associate

37757692 Sr. QC Associate Fremont, CA 12 Months

Sigma Inc is currently looking for a QC Associate to work in with our client in Fremont, CA

1st Shift: Mon- Fri 8.00 AM - 5.00 PM

• The SR QC Associate is assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing. • This role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable). • The SR QC Associate coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs). • This role performs duties under limited supervision and according to standard operating and QC procedures. • Trains other associates and technicians on methods and processes.

Responsibilities:

• Executes independently, with adequate training, three to five (3-5) analytical testing methods with different analytical principles under minimum oversight by qualified staff. • Manages and reviews fundamental tasks such as but not limited to buffer prep, TCU maintenance, and cleaning. • Identifies and implements fundamental improvements to lab processes compliance activities. • Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs). • Documents work according to cGMP and cGDP. • Adheres to established regulations and follows cGMP established by site. • Reports abnormalities and deviations in a timely and accurate manner. • Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately. • Maintains and improves lab areas according to predefined standards (5s). • Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. • Conduct group training on compliance topics and scientific principles as needed. • Performs testing and review within several different analytical technologies. • Reviews and trends analytical data and compliance processes to identify out of trends. • Authors routine compliance documents. • Identifies process anomalies and areas for improvement for operations. • Provides compliant and smart solutions for moderately complex methods and testing issues. • Coordinates work within the team and cross functionally. • Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place. • Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions. • Trains other associates and technicians on methods and compliance.