batch-records jobs in San Diego

The QA Associate II supports quality assurance operations in a regulated manufacturing environment, ensuring materials, processes, and products comply with cGMP and company procedures. Responsibilities include reviewing batch records and analytical data, assessing deviation and CAPA closure, conducting GMP documentation reviews and line clearance inspections, and supporting material/equipment qualification and audit activities.…See more The role requires independent judgment on routine quality decisions, cross-functional collaboration with Manufacturing, QC, and other departments, and the ability to draft and revise SOPs and quality documentation. A Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment are required; cell therapy, aseptic technique, and cleanroom experience are valued.

Sr. Research Associate will design and execute design-of-experiments (DOEs) to optimize surface chemistry processes for in vitro diagnostic systems, transitioning formulations from R&D through pilot scale-up and manufacturing under GMP/FDA design control.…See more The role requires hands-on expertise in fluorescence imaging/spectroscopy, microfluidics, molecular biology techniques (nucleic acid extraction, PCR, amplification), and consumable characterization—including test method design, acceptance criteria definition, and root-cause analysis. The candidate will author technical documentation (protocols, batch records, DHF submissions), collaborate cross-functionally with assay development, reagent chemistry, device engineering, manufacturing, and quality/regulatory teams, and support FDA submissions (510(k)/PMA, CE-IVDR). Strong systematic troubleshooting, laboratory skills, and ability to present data to leadership are essential.

QA Associate II supports manufacturing operations at a cell-therapy biotech company, reviewing batch records, analytical results, and quality documentation to ensure compliance with cGMP and company procedures. The role involves assessing deviations and CAPAs, conducting line clearance inspections, performing GMP documentation reviews, and supporting material/equipment qualification and audit activities.…See more The person will exercise judgment on routine and moderately complex quality issues, escalate concerns appropriately, and collaborate cross-functionally with Manufacturing, QC, and Facilities. The position requires a Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment.