QC Associate II

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

Responsible for assisting the Quality Control Manager in achieving compliance with all Federal and State accrediting agency requirements in the testing of biopharmaceutical and genetic products manufactured in the in the various City of Hope Good Manufacturing Practices (GMP) facilities. Performs quality control assays, release tests and assay development tasks. Provides qualification and validation support for manufacturing processes and quality assurance procedures that are essential to the cGMP production of biomedical products, including appropriate and accurate documentation.

Key Responsibilities include:

• Performs release testing on manufactured products following established SOP. Develop and adapt new procedures for testing when necessary. Complete all documents associated with the testing in compliance with cGMP.
• Assists in creating, reviewing, and revising Standard Operating Procedures as necessary.
• Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and APCF procedure requirements.
• Participate in general laboratory activities as assigned by supervisor.
• Complete and maintain all training required to perform assigned tasks.
• Cooperates with other performance improvement and compliance activities within the department and in the institution.
• Maintains current knowledge of analytical techniques and industry practices.

Basic education, experience and skills required for consideration:

• Bachelor's or Masters degree with relevant laboratory work experience/knowledge in Biology (Molecular and Cellular) and Chemistry (Inorganic, Organic and Biochemistry) required
• 2-3 years of experience post-Bachelors degree work experience within a laboratory or 1-2 years of experience post-Masters degree work experience in a laboratory
• Technical understanding/experience with PCR, ELISA, FACS and developing assays is preferred.
• Experience working in a cGMP manufacturing environment within Cell Therapy or Biologics is desirable

Additional Information:

• To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

• Posting Date: Nov 23, 2021
• Job Field: Research
• Employee Status: Regular
• Shift: Day Job