QC Associate III - CBG

Location
Duarte, California
Salary
Competitive
Posted
September 21 2021
Ref
10013144
Position Type
Full Time
Organization Type
Healthcare/Hospital
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, cellular and genetic products manufactured in the Center for Biomedicine and Genetics (CBG). 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. Guides and trains new and/or junior Quality Control Associates. Assists Quality Control Manager in coordinating day-to-day Quality Control functions including release testing, stability testing and testing to support manufacturing processes. Performs first-round batch record and summary report reviews before the final approval by the Quality Control Manager.

Key Responsibilities include:
  • Perform 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 to cGMP.
  • Create, review, and revise Standard Operating Procedures as necessary.
  • Create summary reports, including analytical summaries, Certificate of Analysis, stability report, and assay development reports.
  • Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and CBG procedure requirements.
  • Participate in general laboratory activities as assigned by supervisor.
  • Complete and maintain all training required to perform assigned tasks.
  • Cooperate with other performance improvement and compliance activities within the department and in the institution.
  • Maintain current knowledge of analytical techniques and industry practices.
  • Present analytical results and progress and assay development result to Management team and Project team on a regular basis.
  • Possess and demonstrate integrity and honesty in maintaining confidentiality. Follows established City of Hope and departmental policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines.


Basic education, experience and skills required for consideration:
  • Bachelor's degree with 6-8 years of industry experience or Masters degree with 5-8 years of industry experience
  • Background within molecular biology and cellular biology, protein chemistry, biostatistics, biosafety training, chemical safety training and cGMP principles and practices.
  • Experience working with release testing of cGMP products, analytical science and assay development is desirable.
  • Biotechnology and/or Pharmaceutical industry experience is preferred.


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.

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  • Posting Date: Sep 20, 2021
  • Job Field: Research
  • Employee Status: Regular
  • Shift: Day Job

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