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QC Associate

Company: Apex Systems
Location: Ventura
Posted on: October 8, 2020

Job Description:

Seeking a QC Research Associate This individual will support manufacturing and technical operations by executing analytical assays for product release with emphasis in cell-based bioassays (cell counts, flow cytometry, Cytotoxicity assays etc). Primary Responsibilities Performs routine testing on final product clinical and commercial lots. Act as SME for analytical methods, troubleshooting, investigations, technical reports and protocol writingrevision. Supports the qualification of a GMP compliant QC bioanalytical laboratory. Participates in the validation and technical transfer of analytical methods. Help to draft SOPs, test methods, technical reports, and validation protocols. Executes method validation protocols and writes validation reports. Supports QC- Analytical management during internal and external inspections and audits. Support nonconformance investigate, root cause analysis and implement solutions. Works within QAQC and will be expected to interact regularly with manufacturing, process development and supply chain. Will be expected to support technical transfer of assays from development into QC, participate in all assay validations, and perform routine GMP testing of clinical and commercial products in compliance with GMP regulations Basic Qualifications Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology with 5 or more years of experience or an equivalent combination of education and experience. Quality control experience in the pharmaceutical industry supporting cGMP areas, including assay validation preferred. Experience in cGMP cell therapy manufacturing andor testing facility is a plus. For consideration please email most up-to-date resume with contact information to Brittany Waldron LI-BW4 EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

Keywords: Apex Systems, Ventura , QC Associate, Other , Ventura, California

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