Full-Time
Quality Assurance Analyst
Deadline 9/30/26
University of California - Irvine
Research university in Irvine, CA
No salary listed
Irvine, CA, USA
In Person
Bachelor's
Category
 Biology & Biotech (1) |
|---|
Required Skills
Inventory Management
Quality Assurance (QA)
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Requirements
- Adhere to excellent customer service principles.
- Prioritize duties in an ever-changing environment using strong organizational skills.
- Possess technical vocabulary sufficient to meet facility needs.
- Have a deep understanding of current good manufacturing practice regulations and global guidelines from agencies such as the Food and Drug Administration and European Medicines Agency.
- Listen, collect information, and give instructions to support, clarify, or resolve problems.
- Use personal computer, word processing, data management, and spreadsheet software.
- Understand standard precautions, biosafety, Occupational Safety and Health Act requirements, and laboratory safety regulations.
- Draft and review audit-ready Standard Operating Procedures, batch records, and technical reports with clear written and oral communication.
- Write clear technical reports in scientific format and ensure records are Attributable, Legible, Contemporaneous, Original, and Accurate.
- Maintain appropriate interdepartmental communication.
- Conduct internal audits and prepare for regulatory inspections by managing documentation and hosting inspectors.
- Work under pressure to meet commitments and remain flexible with changing demands.
- Identify minor discrepancies in batch records or production processes that could lead to product recalls.
- Work effectively as a team member and assist colleagues as needed.
- Function effectively in a diverse work environment.
- Use electronic systems for managing deviations, corrective and preventive actions, and change controls.
- Understand federal and state legislation and regulatory requirements pertaining to cellular therapy production.
- Hold a bachelor's degree in Nursing or another relevant healthcare profession, or have comparable clinical education and/or experience.
- Have at least 1 year of experience in toxicology, chemistry, or regulation of biologics.
- Review current good manufacturing practice and good laboratory practice documents, including Standard Operating Procedures, protocols, batch records, and technical reports.
Responsibilities
- Support the Quality Assurance Unit in the School of Medicine's current good manufacturing practice facility.
- Perform Quality Assurance activities supporting current good manufacturing practice manufacturing operations and process development activities.
- Issue and reconcile product labels.
- Issue and review batch records.
- Receive and release starting materials, including cell banks.
- Perform product disposition and inventory management.
- Issue and manage logbooks, including equipment-use and facility-cleaning logbooks.
- Support project teams in developing and implementing standards for inspection and accreditation.
- Coordinate, prepare, and submit Investigational New Drug applications.
- Evaluate completed manufacturing records from contract manufacturing organizations, including batch records, certificates of conformance, certificates of analysis, packaging records, and related data, to ensure accuracy and completeness.
- Collaborate with stakeholders on compound- and product-specific risk assessments for drug development activities.
- Review development and qualification protocols and reports.
- Participate in compliance activities involving quality systems, internal Standard Operating Procedures, deviations, out-of-specification results, product complaints, corrective and preventive actions, change controls, and regulatory requirements.
- Prepare for external inspections, respond to inspection deficiencies, and set policy for Quality Assurance and compliance activities.
- Develop, maintain, and enforce the quality plan.
Desired Qualifications
- Two years of experience in clinical laboratory setup.
University of California - Irvine is a public research university in Irvine, California. It offers undergraduate, graduate, and professional education across its schools and academic programs.
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