Quality Assurance Analyst

Who We Are

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation, and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.

It is located in one of the world’s safest and most economically vibrant communities and is Orange County’s second‑largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.(Use the "Apply for this Job" box below)..edu

Experienced professional who knows how to apply theory and put it into practice with in‑depth understanding of the professional field; independently performs the full range of responsibilities within the function; possesses broad job knowledge; analyzes problems and issues of diverse scope and determines solutions.

The Quality Assurance (QA) Specialist will support a Quality Assurance Unit in the School of Medicine, cGMP Facility. The QA Specialist will report administratively to the Manager of Quality Assurance for GMP Operations. The QA Specialist will perform Quality Assurance activities to support GMP manufacturing operations and process development, including but not limited to product label issuance and reconciliation, batch record issuance and review, starting material (Cell Banks) receipt and release, product disposition and inventory management, logbook issuance and management.

In addition, the QA Specialist will support project teams in developing and implementing standards for inspection and accreditation, coordinating, preparing, and submitting Investigational New Drug (IND). The role will evaluate compliance of completed manufacturing records and collaborate with stakeholders to conduct risk assessments. Responsibilities include reviewing development and qualification protocols and reports, ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls, and regulatory requirements.

The position requires specialized knowledge for reports, external inspections, and policy setting for quality assurance and compliance activities. The QA Specialist is responsible for development, maintenance, and enforcement of the quality plan.

• Adherence to excellent customer service principles.
• Organizational skills sufficient to prioritize duties in an ever-changing environment.
• Possess technical vocabulary to meet facility needs.
• Deep understanding of cGMP regulations and global guidelines from FDA and EMA.
• Ability to listen, collect information, and give instructions to support, clarify, or resolve problems.
• Knowledge of personal computer, word processing, data management, and spreadsheet software.
• Knowledge of standard precautions and biosafety. Knowledge of OSHA and laboratory safety regulations.
• Outstanding written and oral communication skills, including drafting and reviewing audit‑ready SOPs, batch records, and technical reports.
• Must write clear technical reports in scientific format, ensuring all records are attributable, legible, contemporaneous, original, and accurate.
• Maintains appropriate interdepartmental communication.
• Experience conducting internal audits and preparing for regulatory inspections by managing documentation and hosting inspectors.
• Ability to work well under pressure to meet commitments and to remain flexible with a variety of changing demands.
• Essential for catching minor discrepancies in batch records or production processes that could lead to product recalls.
• Ability to work as a member of a team and to assist colleagues as needed.
• Ability to function and work in a diverse work environment.
• Proficiency in using electronic systems for managing deviations, CAPAs, and change controls.
• Knowledge of federal and state legislation and regulatory requirements pertaining to cellular therapy production.
• Bachelor's degree in Nursing or other relevant healthcare profession, or a combination of comparable clinical education and/or…