Analyst, Quality Control (Raw Materials) -???????????-??????????-
Company: Kelly Services
Posted on: February 8, 2019
Quality Control (Raw Materials) - Irvine, CA Position Summary: Perform sampling and release testing of raw materials, equipment parts, and regents to support manufacturing, validation, process development, stability studies, and lot release testing. Continuously work to improve and develop cGMPs and the quality system. Essential Duties and Responsibilities: Visually inspect purchased materials such as chemicals, buffers, or components used by the laboratory and/or manufacturing per internal raw material specifications. Review supplier CofA for conformance to internal specifications. Review and approve assays and documents for material release. Perform testing per internal test methods. Perform testing per USP and EP monographs. As required, gown and perform testing in the manufacturing facilities/clean room areas. Perform aseptic sampling of raw materials/components. Ability to perform minor troubleshooting of the methods and instruments used for testing (FTIR, pH, conductivity, iEF, endotoxin, routine wet chemistry ID testing). Revise internal documents (SOP, TM, RMS, forms, etc) using the DCR process, as required. File/copy test reports and protocols, compile reports, document and label samples, complete submission forms/cover letters/purchase orders for contract testing labs. Must be able to use Microsoft word and Microsoft excel. Communicate and interact with employees outside the group. Communicate and interact with external vendors/suppliers of raw materials/components. Support continuous improvement initiatives. Has a working knowledge of GMP principles and requirements. Participate in investigations and development projects. Proactively identifies and communicates issues such that they can be solved before they can have a detrimental effect on the organization. Operates effectively in a fast-paced work environment. Job Requirements: Associates degree: 4-6 years of related experience in the biotechnology/pharmaceutical industry or combination of education and experience or Bachelor's degree: 2-4 years of related experience in the biotechnology/pharmaceutical industry or combination of education and experience. Basic knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures. Good understanding of cGMP and GDP Good verbal and written communication skills. Ability to work under minimal supervision to complete assigned tasks in a timely manner. For immediate consideration, apply today Questions? Call Toni at 714.971.0721 Why Kelly -- ? With Kelly, you'll have access to some of the world's highest-regarded scientific organizations- providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 95 of the Fortune 100--- companies, and found opportunities for more than 9,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today. About Kelly Services -- As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
Keywords: Kelly Services, Tustin , Analyst, Quality Control (Raw Materials) -???????????-??????????-, Professions , Tustin, California
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