#123149 Quality Assurance Associate

DESCRIPTION

The Advanced Cell Therapy Laboratory (ACTL) offers expert assistance and hands-on services to investigators who require cGLP/cGMP systems and facilities. We aid in the transition from research and development to compliant and clinically-relevant manufacture of cell therapy products for IND-enabling studies or Phase I/II trials.

The Quality Assurance Associate for the UCSD Advanced Cell Therapy Laboratory (ACTL) will help maintain Quality oversight of all departments at ACTL. This position will help confirm that the manufacturing facility and personnel maintain compliance with internal procedures and current GMPs. The QA Associate will participate in oversight of the QMS and manufacturing processes. They will aid the QA Manager in performing internal audits for compliance control and external vendor qualifications. They will also participate in quality audits by perspective clients and regulatory agencies. They will also aid in quality events and investigations as needed.

This position will aid the QA Manager in matters of Quality compliance issues. Review production batch records and associated data for product release. Determines if records comply with cGMP regulations. Reviews data obtained for compliance specifications and reports abnormalities. This position will also ensure quality by giving line clearances, aid in revising standard operating procedures and train personnel as necessary. Review and release of raw material and process consumables to ensure all materials used in manufacturing are in compliance with written specifications.

CT: Applies acquired skills and professional concepts for small to medium regulatory healthcare compliance projects of intermediate scope and complexity.

MINIMUM QUALIFICATIONS

• Proven project management skills and the ability to effectively manage time, organize competing priorities, address complex issues as they arise, and see projects through to completion on schedule.
• Six (6) years of relevant experience in Quality Assurance or Quality control or a Bachelor's degree in life sciences or a related field and two (2) years of relevant experience in Quality Assurance or Quality control required.
• Effective interpersonal skills for collaborating effectively with a broad range of managers and staff and with representatives of external regulatory agencies.
• Thorough knowledge and understanding of compliance and regulatory standards across the healthcare industry or within a specialty area including pharmaceutical QMS.
• Strong skills in written and verbal communications, with the ability to convey complex technical information, education, and instructions in a clear and concise manner, and to produce high-quality reports and documentation.
• Working knowledge of the methods, tools, and practices involved with regulatory compliance, including GMP regulations 21 CFR Part 11, 210/211, 600, and 820..
• Demonstrates working knowledge of quality assurance systems, methods and procedures.

SPECIAL CONDITIONS

• Must be able to maintain confidentiality.
• Must be able to work various hours and locations based on business needs.

Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

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UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.