QA Associate II-CATD

Location
California
Salary
Competitive
Posted
November 09 2018
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
QUALITY ASSURANCE ASSOCIATE (LENTIVIRAL VECTOR MANUFACTURING) sought by Beckman Research Institute of the City of Hope in Duarte, CA.

Duties: Perform quality assurance activities for the manufacture and release of clinical grade biological and cellular products. Act as a subject matter expert and direct activities between Lentiviral vector manufacturing, quality control and quality assurance teams. Lead viral vector/gene therapy production projects that includes Lentiviral vector manufacturing, Adenovirus, Modified Vaccinia Ankara virus, and Poxvirus vector manufacturing projects. Issue production batch records. Audit the manufacturing production activities. Provide technical review of the production output batch records of viral vectors and assure that the proper procedures and processes have been used in the production of viral vectors/biological products. Compile master production and control batch records. Initiate OOS/CAPA (corrective and preventative) investigations, propose resolutions, close-out investigations and process related forms. Review new and revised viral vector manufacturing SOP's and release them for manufacturing. Interact with external collaborators at project meetings and present project updates. Communicate with external vendors as directed. Coordinate release tests activities and materials processing of biological and cellular products. Ensure compliance with all federal and state laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of viral vectors, including Lentivirus, adenovirus, AAV, MVA manufactured in the cGMP facilities at City of Hope (COH) for use in early phase clinical trials.

Requirements: Bachelor's degree or equivalent in Molecular Biology, Biochemistry, Biology or a related field, plus three (3) years of experience as a Quality Assurance Associate, Research Associate or related occupation, including experience in writing and revising quality assurance policy SOP's (Standard Operating Procedures) in accordance with FDA regulations of gene therapy and viral vector manufacturing; working on Lentiviral, Retroviral, Adenoviral, AAV and MVA manufacturing, and viral vector final fill; experience with Quality Control Release testing and Assays including p24 ELISA, Flow Cytometry, Transfer of Residual DNA (SV40, E1A, VSVG), and Mycoplasma; working with aseptic technique including cell culture, Transfection/Transduction, Harvest, clarification and concentration of viral vectors including Lentivirus, Adenovirus and MVA; and utilizing Labware/LIMS software.

OR

Master's degree or equivalent in Molecular Biology, Biochemistry, Biology or a related field, plus one (1) year of experience as a Quality Assurance Associate, Research Associate or related occupation, including in writing and revising quality assurance policy SOP's (Standard Operating Procedures) in accordance with FDA regulations of gene therapy and viral vector manufacturing; working on Lentiviral, Retroviral, Adenoviral, AAV and MVA manufacturing, and viral vector final fill; experience with Quality Control Release testing and Assays including p24 ELISA, Flow Cytometry, Transfer of Residual DNA (SV40, E1A, VSVG), and Mycoplasma; working with aseptic technique including cell culture, Transfection/Transduction, Harvest, clarification and concentration of viral vectors including Lentivirus, Adenovirus and MVA; and utilizing Labware/LIMS software.

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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