gmp 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.

Senior software engineer role building autonomous cell-therapy manufacturing instrument software in a regulated environment. Responsibilities span instrument control software architecture, firmware-hardware integration, data pipeline management, CI/CD and SDLC practices, and regulatory documentation.…See more Requires 7+ years developing software for instruments, medical devices, or laboratory automation under regulated lifecycles, with strong C++, Rust, or Python, closed-loop control experience, state-machine architectures, and a safety-critical mindset.

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.

Sr. Specialist overseeing quality assurance systems, records management, and compliance in a pharmaceutical/biotech GxP-regulated environment.…See more Responsibilities include managing electronic quality systems, processing controlled documents and SOPs, supporting inspections and audits, analyzing quality metrics and dashboards, leading process improvement initiatives, and mentoring junior staff. Requires a bachelor's degree with 4+ years of pharma/biotech QA experience (or master's with 2+), strong knowledge of FDA/ICH/GMP/GLP/GCP regulations, proficiency with QMS and LMS platforms, and demonstrated leadership and analytical capabilities.

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.

This role involves designing, developing, and implementing Körber PAS-X Manufacturing Execution Systems (MES) for life sciences manufacturing environments. Responsibilities include configuring Electronic Batch Records (EBRs), integrating MES with ERP and control systems, and ensuring GxP compliance and FDA/GMP adherence.…See more The consultant will document MES configurations, validate solutions, and work directly with clients to define strategic needs and deliver value-added solutions. Minimum 2 years of hands-on PAS-X MES experience in highly automated life sciences manufacturing is required.

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.

Quality Assurance Specialist II leads and supports audit activities, serves as a QA subject matter expert during inspections, and manages quality events and risk assessments for medical device products. The role involves conducting root cause analyses, managing document control and training workflows, coordinating the internal audit program, and driving quality-system improvement projects.…See more The position requires a bachelor's degree in a scientific or engineering discipline with 3–5 years of QA or regulatory affairs experience in a regulated industry, with medical device experience highly preferred. Key responsibilities include compliance with ISO 13485 and 21 CFR Part 820, partnership with senior quality engineers on risk management, and eQMS implementation and validation.

Global Support Engineer will provide Level 2/3 technical support for complex instrumentation in a biotech environment, diagnosing issues across mechanical, fluidics, optics, electronics, and firmware subsystems. The role includes triaging escalations, authoring technical documentation and service bulletins, supporting new product introductions, and serving as an on-site diagnostic resource to field service teams.…See more Requires a bachelor's degree in engineering and 2–5 years of field service or technical support experience in instrumentation or regulated biotech/medical device industries.

This Quality Assurance Engineer role supports medical device product development and sustaining engineering teams by developing and implementing quality test procedures, test equipment protocols, and sampling plans. The engineer will conduct product investigations, corrective/preventive actions, regulatory submissions support, and statistical analysis of production data—all in compliance with industry standards (ISO 14971), GMP, and regulatory requirements.…See more The role requires 4+ years in medical device/pharmaceutical quality engineering or equivalent advanced degree with 2+ years of relevant experience, with expertise in test method validation, equipment qualification (IQ/OQ/PQ), risk management documentation, and analytical equipment validation.

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.

Lead compliance testing and certification activities for a portfolio of medical devices, developing test strategies, managing external laboratories and certification bodies, and ensuring products meet FDA, safety, EMC, wireless, and regulatory requirements. Partner with Engineering, Quality, and Regulatory Affairs to identify compliance risks early and drive mitigation strategies.…See more Manage a team of compliance engineers and test professionals, oversee departmental budgets, and continuously improve compliance testing processes and best practices.

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.