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Details
Posted: 10-Oct-23
Location: Irvine, California
Type: Full-time
Salary: Open
Categories:
Human Resources
Internal Number: 4675092
University of California Irvine
Quality Assurance Manager
Updated: Oct 8, 2023
Location: Irvine-Campus
Job Type:
Department: SOM Office of Research
Job Opening ID: 60224
Reports To: Director of Research Operations
Working Title: Quality Assurance Manager
Department: SOM Office of Research
Bargaining Unit: 99
FLSA: Exempt
Payroll Job Code: 006525
Job Location: UCI Campus- Irvine
Percent of Time: 100%
Work Schedule: 8-5, M-F
Employee Class: Career
Position Summary:
The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory.
Oversees a Quality Assurance Unit in the School of Medicine, supporting the GMP Facility and by supporting project teams in developing and implementing standards for inspection and accreditation. Responsible for raw material inspection and release, Quality on the floor, disposition of drug product/drug substance, QA review of quality control data, root cause analysis, risk management, technical writing, deviation, change control and CAPA management, document/record management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/facilities qualification and continuous improvement, Responsible for ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality system implemented effectively, and compliant site. Help build scalable, phase appropriate quality systems as organization continues to grow.
Total Compensation:
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 a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.
$111,200.00 - $163,100.00 (Annual Salary) Expected Pay Range within the Full Salary Range $100,600.00 - $190,800.00 (Annual Salary)
Required:
5 years of experience in quality assurance, preferably within a GMP environment 2+ years management experience
Management of Quality Assurance Unit
Preferred:
Experience in the use of Six Sigma, DMAIC methodology, and/or quality improvement statistical tools. Hands-on experience in Quality Risk Management principles and tools (e.g., FMEA, RCA) In depth knowledge in 21CFR Part 11 , 21CFR 210, 21CFR211, 21CFR600 and 21CFR610.
Conditions of Employment:
The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:
Background Check and Live Scan
Legal Right to work in the United States
Vaccination Policies
Smoking and Tobacco Policy
Drug Free Environment
The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
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, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination 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
Job Opening ID: 60224Reports To: Director of Research OperationsWorking Title: Quality Assurance ManagerDepartment: SOM Office of ResearchBargaining Unit: 99FLSA: ExemptPayroll Job Code: 006525Job Location: UCI Campus- IrvinePercent of Time: 100%Work Schedule: 8-5, M-FEmployee Class: Career
Conditions of Employment:
The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:
Background Check and Live Scan
Legal Right to work in the United States
Vaccination Policies
Smoking and Tobacco Policy
Drug Free Environment
The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
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, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination 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
To apply, visit https://careersucirvine.ttcportals.com/jobs/13450208-quality-assurance-manager
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Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.
More Jobs from This Employer
https://careers.cbia.org/jobs/19257886/quality-assurance-manager
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