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Quality Assurance AnalystUniversity of California Irvine Health • Irvine, California, United States
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Quality Assurance Analyst

University of California Irvine Health
  • US
    Irvine, California, United States
  • US
    Irvine, California, United States
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À propos

Req ID: 148411 Location: Irvine, California Division: School of Medicine Department: CGMP Facility Position Type: Full Time Salary Range Minimum: USD $97,000.00/Yr. Salary Range Maximum: USD $182,200.00/Yr.
Your Role on the Team 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 / issues of diverse scope and determines solutions.
What It Takes to be Successful Required:
Adherence to excellent customer service principles.
Organizational skills to prioritize duties in an ever-changing environment.
Must possess technical vocabulary to meet facility needs.
Deep understanding of cGMP regulations and global guidelines from agencies like the FDA and EMA.
Ability to listen, collect information, and give instructions in an effort 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. The ability to draft and review Standard Operating Procedures (SOPs), batch records, and technical reports that are audit-ready and clear.
Must be able to write clear technical reports in the 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 experience.
At least 1 year of experience in toxicology, chemistry, regulation of biologics.
Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.).
2 years of experience in clinical laboratory setup
Total Rewards In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to discounts and perks.
Conditions of Employment The University of California, Irvine seeks to provide a safe and healthy environment for the entire UCI community. All applicants who accept an offer of employment must comply with the following conditions of employment:
Background Check and Live Scan
Employment Misconduct*
Legal Right to work in the United States
Vaccination Policies
Smoking and Tobacco Policy
Drug Free Environment
Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
California Child Abuse and Neglect Reporting Act
E-Verify
Pre-Placement Health Evaluation
Details of each policy may be reviewed by visiting the following page: https://hr.uci.edu/new-hire/conditions-of-employment.php
Closing Statement The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy. We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.
Must be able to provide proof of work authorization
To apply, visit https://jobs.uci.edu/careers-home/jobs/148411
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  • Irvine, California, United States

Compétences linguistiques

  • English
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