Manufacturing Quality Systems Specialist - Downstream, Irvine area, CA
Company: Kelly Services
Posted on: February 8, 2019
Manufacturing Quality Systems Specialist - Downstream, Irvine area, CA Are you a Subject Matter Expert for Downstream operations? If so, we have an opportunity for you to improve patient lives through our manufacturing operations for clinical trial products Summary/Objective: The Specialist, Manufacturing Quality Sciences will assist in the technical transfer of process from client (s) and/or Process Sciences to Manufacturing scale. Responsible for continuous process improvement in manufactured products. Where issues or improvements are identified, this role will propose viable solutions including a final product impact assessment. Will identify elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need a complete revision. Review discrepancies, assist investigation activities and prepare a CAPA as appropriate. Propose innovative methods/procedures for gap analysis and reduction of deviations. Will prepare written reports and presentations for meetings as assigned. Review 'Engineering Run' Batch Records prior to final QA review and approval. Shift: Full-time, flexible scheduling due to operations/scheduling; Monday through Friday 8:00am to 5:00pm, weekend work as necessary. Job Duties and Responsibilities: Function as SME on the production floor for both Upstream and Downstream operations Actively assist in the technology transfer from Process Development to cGMP Manufacturing. Assist in the design and execution of studies to support MFG production. Perform gap analyses on tech transfers. Write technical risk assessments. Identify and implement efficiencies for manufacturing processes. Ability to quickly identify process issues and resolve them expeditiously Ability to perform sound root cause investigations and identify correct CAPAs Review batch production records for engineering runs Job Requirements: Bachelor's degree (BS) in Life Sciences or Engineering or higher is required. Biopharmaceutical experience is required - the incumbent may possess 2 to 3 years in technical experience in industry or in graduate level studies, or equivalent combination of education and experience. Minimum of 2 - 3 years' experience working with biologics purification. Ability to think creatively to address complex problems. Ability to understand basic cell culture, bioreactor, chromatography theory, viral filtration, and ultrafiltration and be able to apply it to real-time scenarios. Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write technical reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. For Immediate consideration, Apply Today Questions? Call Grace at 714-917-0721 or Email grace.piperkellyscientific.com 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 , Manufacturing Quality Systems Specialist - Downstream, Irvine area, CA, Other , Tustin, California
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