deviation-management 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.

The QA Associate II reviews manufacturing batch records, analytical test results, and quality documentation to ensure compliance with cGMP and company procedures. Responsibilities include assessing deviations and CAPAs, conducting line clearance inspections and process observations, supporting material and equipment qualification, and participating in audits and investigations.…See more The role requires judgment in routine and moderately complex quality decisions, cross-functional collaboration, and SOP documentation in a regulated biopharmaceutical manufacturing environment.

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.

Support Computer System Validation (CSV) activities for GxP-regulated pharmaceutical and medical device systems, including validation planning, test execution, documentation, and compliance verification against FDA regulations and 21 CFR Part 11. Execute validation test scripts, document results and deviations, conduct impact and risk assessments, and collaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.…See more Maintain validation records, support change control and CAPA activities, and identify compliance gaps in regulated computerized environments.

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections.…See more The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.

This Quality Assurance Specialist II role supports clinical trial projects at a pharmaceutical CDMO, ensuring compliance with cGMP and SOPs throughout the product lifecycle. Responsibilities include pre- and post-execution batch record review, authoring/updating QA and compliance documentation, participating in investigations and deviation writing, and reviewing change controls.…See more The candidate must demonstrate strong knowledge of GMP environments, proficiency with MS Office (especially Excel) and ERP systems like JD Edwards, and 5–10+ years of relevant pharmaceutical QA experience depending on education level.