Payroll Title:
RSCH DATA ANL 2 Department:
ADV CELL THERAPY LABORATORY Hiring Pay Scale
$67,200 - $75,000 / Year Worksite:
La Jolla Appointment Type:
Career Appointment Percent:
100% Union:
Uncovered Total Openings:
1 Work Schedule:
Days, 8 hour shifts, Monday - Friday

#130813 Quality Control Associate
Filing Deadline: Tue 7/16/2024
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UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.

UCSD Layoff from Career Appointment : Apply by 7/05/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants : Apply by 7/16/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.

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. We provide assistance with cell banking, process development and scale-up, product characterization, document writing, product stability assessment, and packaging.

Incumbent will focus on QC activities supporting the manufacturing of cell therapy products. This includes release and stability testing of cell therapy products, maintaining the QC laboratory and instruments, authoring and revising standard operating procedures (SOPs) & certificates of analysis, and managing off-site testing of QC samples. Will perform environmental monitoring of the facility monthly and to support product fills as needed.

Works on research data reporting assignments that are of moderate diversity in scope. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

MINIMUM QUALIFICATIONS

• 6 years of related experience, education/training, OR a Bachelor's degree in related area (scientific discipline)plus 2 years of related experience/training.
• Working knowledge of research function. Knowledge of test methods used to test cell therapy products or similar characterization assays.
• Skills to communicate complex information in a clear and concise manner both verbally and in writing.
• Willingness to adhere to established UCSD guidelines for safety and environmental issues.
• Working skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.
• Experience using basic laboratory equipment; knowledge of safe laboratory procedures.
• Working skills in statistical analysis, systems programming, database design and data security measures.
• Strong organizational skills with ability to prioritize tasks and to work under the pressure of multiple demands.

PREFERRED QUALIFICATIONS

• Familiarity with the Miltenyi CliniMACs or similar flow cytometry devices, QPCR intruments, and absorbance readers.
• Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.
• Strong skills using FlowLogic, MACSQuantify, FACS DIVA, or similar, as well as MS Word and Excel.
• Working knowledge of laboratory Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), United States Pharmacopeial Convention (USP), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulations.

*Environmental Monitoring Experience.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.
• Willingness to work in Biosafety Level II environment where biological (including infectious agents and blood borne pathogens) hazards are present.
• Willingness to work with embryonic stem cells, work with viruses that are infectious to humans, including adeno-associated viruses, Sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).
• Must be able to work various hours and locations based on business needs.

Pay Transparency Act

Annual Full Pay Range: $67,200 - $119,600 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $32.18 - $57.28

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).

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If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

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!

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UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20
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