Quality Control Manager

UCSF Medical Center
  • San Francisco, CA
    30+ days ago

    Job Description

    The Quality Control Manager applies extensive knowledge of clinical radiopharmaceuticals to ensure the quality of investigational radiopharmaceuticals specified by the standards stated in the USP Chapter <823> and the laboratory requirements of 21 CFR 212. This position will report to the Director of the Radiopharmaceutical Facility in the development of quality control standard operating procedures for the investigational PET drugs such that the facilities, equipment, and inventory control meet the associated regulatory requirements. This position will also assist in creating new approaches in the quality control of novel radiopharmaceuticals for clinical use, and in working with the director in writing investigational drug applications (IND) and Abbreviated New Drug Applications (ANDA). The background for this position requires a minimum of a BS in chemistry or related subject with at least 5 years experience in a GMP radiopharmaceutical facility.

    About UCSF

    The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

    Pride Values

    UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

    In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.

    Join us to find a rewarding career contributing to improving healthcare worldwide.

    Equal Employment Opportunity

    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 status under state or federal law.

    Salary Information

    The final salary and offer components are subject to additional approvals based on UC policy.

    Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

    To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

    Required Qualifications

    • Bachelor''s degree in chemistry or related area
    • Minimum of 5+ years of related experience
    • 3 years' experience in quality control of cGMP PET Radiopharmaceuticals
    • Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
    • In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems
    • Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals

    Preferred Qualifications

    • Master's degree in chemistry or related area
    • Knowledge of 21CFR212 and USP 823 regulatory requirements

    Numbers & Facts

    LocationSan Francisco, CA

    Skills

    • Abbreviated New Drug Applicationunmatched
    • Biologyunmatched
    • Biomedical Researchunmatched
    • Cancerunmatched
    • Chemistryunmatched
    • Code of Federal Regulationsunmatched
    • Community and Social Servicesunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Diseaseunmatched
    • Diversityunmatched
    • Equal Employment Opportunity (EEO)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Health Scienceunmatched
    • Healthcareunmatched
    • Identify Issuesunmatched
    • Interpersonal Skillsunmatched
    • Inventory Managementunmatched
    • Investigational New Drug (IND)unmatched
    • Leadershipunmatched
    • Patient Careunmatched
    • Problem Solving Skillsunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Regulatory Requirementsunmatched
    • Software Developmentunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Standards Developmentunmatched
    • Standards of Careunmatched
    • Stem Cellsunmatched
    • Team Playerunmatched

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