Quality Control Manager-CBG
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Requisition ID: 11266
Job Title: Quality Control Manager-CBG
Manage QC staff to perform QC functions in a most efficient manner. Responsible for assuring compliance with all Federal and State laws & regulations and other accrediting agency requirements in quality control assay development, data collection and evaluation, preparation of laboratory protocols and reports for the release of pharmaceutical and genetic products manufactured in the Center for Biomedicine and Genetics (CBG). Also responsible for quality control of raw materials used in manufacturing. Responsible for development of analytical methods required for product release or in-process sample testing, generating of SOPs, reviewing and approval of all release test results. Oversees quality control staff and maintains the quality control laboratory. Provides validation support for all laboratory equipment, and approves all outcomes, which are essential to the release of biological products. This includes the documentation of processes and maintenance of records. Recruit and provide necessary training to QC staff.
- Performs quality control activities for products to ensure compliance with Good Manufacturing Practices (GMP) for the Center for Biomedicine and Genetics.
- Recruits and oversees QC staff and organizes departmental responsibilities.
- Reviews and revises standard operating procedures as necessary. Assists in the preparation of new standard operating procedures as directed by the Vice President for Technology.
- Reviews and signs off on QC batch records and assures that the proper procedures and processes have been used in the release testing of products and raw materials at CBG.
- Shares responsibility with the QA Officer for preparedness for inspections by regulatory agencies so that there is a positive outcome and a minimum disruption in the daily operation, and insures that agency inspectors are provided with all necessary information. Helps the Sr. VP and Associate Director of the CBG in the preparation of responses to recommendations of other regulatory requirements.
- Reviews all completed QC release test reports and other QC related reports that are generated.
- Maintains knowledge of current advances in laboratory equipment and technologies in molecular and cellular biology.
- May be required to attend pertinent conferences and job related off-site training.
- Cooperates with other performance improvement and compliance activities in the institution.
- Maintains knowledge of current regulatory/accreditation requirements, changes and issues, inspection citations, quality control training, management, and organizational development activities.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Master'sDegree with coursework in biology and/or chemistry
- Five years of quality control/research experience in manufacturing of biologics.
- Skills in PCR, pH meter, Spectrophotometer, Electrophoresis apparatus, Centrifuges (various models), BioSafety Cabinet, Incubator/Shaker required
- Flow cytometry, preferred
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.