Quality Control Specialist

4 weeks ago


Los Angeles, California, United States University of California Full time
Quality Control Specialist

**Job Summary**

We are seeking a highly skilled Quality Control Specialist to join our team at the University of California. The successful candidate will be responsible for leading the establishment of our Human Gene and Cell Therapy Facility (HGCTF) Quality Control laboratory, ensuring compliance with applicable regulations.

**Key Responsibilities**

- Develop and implement a robust training program for QC staff
- Manage the overall operations of the Quality Control unit
- Ensure the HGCTF QC laboratory is in compliance with cGMP regulations
- Develop and/or assess compendial and non-compendial methods for testing of products manufactured/prepared at the HGCTF
- Oversee technology transfer, method development, qualification/validation and/or verification as per applicable guidelines

**Requirements**

- Bachelor of Science Degree or Master's degree in Biology, Chemistry, or related field
- Minimum of five years of GMP quality control experience
- Two years of managerial experience, directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources preferred
- Experience with qualification, technology and method transfer, and validation/verification of analytical methods
- Knowledge of environmental monitoring in a cGMP setting
- Working knowledge of GMP requirements and regulations
- Previous experience directly involved with federal regulations regarding GLP and GMP
- Knowledge of regulatory affairs, quality control and production
- Knowledge of Standard Operating Procedures and Quality Control requirements in a GMP laboratory setting
- Experience in writing SOPs and demonstrated ability to develop and monitor quality improvement plans and SOPs

**What We Offer**

- Competitive salary range: $102,700.00
- Opportunity to work in a dynamic and innovative environment
- Collaborative and supportive team

**How to Apply**

If you are a motivated and experienced Quality Control Specialist looking for a new challenge, please submit your application.

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