document-control 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. 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.

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.

Quality Assurance Analyst II will process change orders and manage training in an electronic quality management system, ensuring compliance with work instructions and coordinating with cross-functional engineering teams. The role involves document control, record organization, logbook management, NCMR/CAPA investigation, and supplier management in a regulated medical device environment.…See more The candidate must demonstrate strong attention to detail, analytical problem-solving, and ability to communicate with multiple departments in a fast-paced setting. A bachelor's degree preferred with minimum 3 years in medical device/biotech quality document control in an FDA or ISO-regulated industry.

This Staff QA Engineer role leads the design, development, validation, and deployment of Quality Assurance metric dashboards for manufacturing operations, with expertise in medical device quality management systems (QMS), regulatory compliance (FDA 21 CFR Part 11, ISO 13485), and non-conforming event management. The position coordinates site and corporate management reviews, participates in internal and external audits, and supports cross-functional teams in CAPA, risk management, and validation activities.…See more The engineer applies statistical analysis and dashboard tools (Power BI, Tableau, SQL, BigQuery) to drive quality decisions and operational excellence. Success requires direct experience with QMS, nonconforming materials, auditing, medical device regulations, and the ability to lead diverse functional groups in a fast-paced environment.

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.