Sr Quality Control Associate - CBG

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Job description

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

Supervise 0-2 direct reports and provide leadership in matrix project team as assigned. Responsible for completing assigned product testing tasks by performing the tasks personally, by directing junior associates, or by coordinating the efforts with project team members. Required to work under minimal or no supervision. Provide written and oral report to management on a regular basis. Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements in the testing of biopharmaceutical and genetic products manufactured at the Center for Biomedicine and Genetics (CBG). Perform quality control assays, release tests and assay development tasks as directed by supervisor. Provide supervision and training to junior team members as directed by supervisor. Perform general laboratory activities occasionally as assigned by supervisor. Provide qualification and validation support for manufacturing processes and quality assurance procedures that are essential to the cGMP production of biomedical products. Perform all cGMP related activities strictly according to SOP with accurate documentation. Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance. Required to wear pager, or other communication devices, and respond to emergency calls.

Responsibilities Include:

* Participate and supervise the testing of biological products.
* Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance.
* Create, review and revise SOP.
* Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements.
* Development/adapt of new analytical methodology independently.
* Perform general laboratory activities as necessary.
* Provide supervision to direct report(s), if any. Utilize proper managerial skills to accomplish assigned tasks.
* Perform, or supervise, release testing following established SOP. Develop and adapt new procedures for product testing when necessary. Complete all documents in compliance to cGMP.
* Create, review and revise Standard Operating Procedures.
* 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. Identify and adapt new analytical methodologies to enhance current capabilities.
* Wear a CBG issued pager, or other communication devices, and respond to all emergency calls promptly at all time for critical equipment failure.
* Internal Contacts:
* With supervisor and project team members within CBG. Report equipment failure or alarms to facility officer, or QA team. Make scientific presentation and progress report to management team on a regular basis.
* External Contacts:
* Communicate with external vendors to obtain technical information as needed. Communicate with external collaborator to discuss assay conditions or troubleshoot when directed by supervisor.
* Budget/Financial Administration: None
* Wear a CBG issued pager, or other communication devices, and respond to all emergency calls for critical equipment failure at all time promptly.
* Attend and complete all mandatory trainings required by City of Hope and Center for Genetics and Biomedicine.
* Attend relevant scientific presentations/conferences as directed by supervisor. Prepare manuscript under minimal supervision.

Basic education, experience and skills required for consideration:

* BS degree in Biological Science or related field, MS preferred. Experience may substitute for minimum education requirements.
* 9+ years of relevant working experience with a BS or MS degree
* Background within Basic Biology (Molecular and Cellular), Chemistry (Inorganic, Organic and Biochemistry), Virology, Immunology, Cancer biology, Chemical engineering, Biotechnology, Analytical chemistry
* Biotechnology, Pharmaceutical industry experience 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.

* Posting Date: Jun 4, 2021
* Job Field: Research
* Employee Status: Regular
* Shift: Day Job