Quality Control Associate II - Cellular Therapeutics - Analytical Pharmacology Core
Job posting number: #7071820 (Ref:10007664rxv_113_1)
Posted: November 5, 2020
Application Deadline: Open Until Filled
Job DescriptionAbout 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.
Exciting opportunity for a Quality Associate II to join the state-of-the-art cellular therapeutics release testing team. Responsible for assisting the Quality Control Manager in achieving compliance with all Federal and State accrediting agency requirements in the Good Laboratory Practices (GLP) compliant final product release testing of cellular therapeutics in the Analytical Pharmacology Core Facility (APCF). Performs quality control assays, release tests and assay development tasks. Provides qualification and validation support for quality control and quality assurance procedures that are essential to the GLP final product release testing 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 GLP.
- 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.
- Possess and demonstrate integrity and honesty in maintaining confidentiality.
Basic education, experience and skills required for consideration:
- Bachelor of Science or Bachelor of Arts with coursework in biology and chemistry required.
- 2-3 years post-Bachelors degree work experience in a laboratory, or 1-2 years post-Masters degree work experience in a laboratory.
- Required courses/training: Basic biology (molecular and cellular), chemistry (inorganic, organic and biochemistry).
- Foster and promote a positive image and professional appearance.
- Organized and efficient; demonstrate proficiency in basic laboratory skills;
- Excellent writing and computer skills; Able to correctly use technical terms and abbreviations.
Preferred education experience and skills:
- Bachelor's or master's degrees with relevant laboratory working experiences.
- Experience working in a GLP or cGMP environment desirable.
- Preferred courses/training: Modern molecular biology, protein chemistry, biostatistics, biosafety training, chemical safety training, GLP principles and practices.
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.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.