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Quality Control Associate

Company: Actalent
Location: Arcadia
Posted on: September 20, 2022

Job Description:

Cancer therapeutic research company in Arcadia looking for an associate to join their team! QC experience required within the biotech industry Description:--- Executes assays to assess various cell and gene therapy products using PCR, Flow Cytometry and cell-based assays for release, in-process and stability samples.--- Implements, and qualifies current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements. Experiences in TOC, pH, Conductivity and Osmolality is preferred.--- Analyzes and summarizes data into reports and certificate of analysis with attention to details.--- Collaborates with other Functional Areas (Analytical Development, Materials Sciences and Technology, Process Development and Manufacturing) for methods transfer, qualifications, validation, sample plan development and timely testing of samples. --- Assists implementation of new methods transferred by the clients and Analytical Development lab.--- Originates and revises QC related procedures and analytical methods.--- Leads and supports invalid assay, exceptions, and lab investigations.--- Maintains lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.--- Reviews and assesses proposed corrective and preventive actions and improvements identified through investigations and audits.--- Performs sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.--- Logs samples into LIMS, labels samples, aliquoting of samples aseptically and distributes to testing departments and external laboratories--- Collaborates with external clients, contractors, and vendors.--- Participates with internal audits and external audits and leads in authoring responses and implementation of actions.--- Other duties as assigned by management.Additional Skills & Qualifications:Bachelor's degree in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required. In lieu of this requirement, work experience may be consideredMinimum of 2 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPExperience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsBasic knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredBasic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsExperience with electronic Laboratory Inventory Management Systems (LIMS) About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Arcadia , Quality Control Associate, Other , Arcadia, California

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