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QA Specialist II QA BSD

Company: Bachem
Location: Vista
Posted on: October 14, 2019

Job Description:

Quality Assurance Specialist II Vista, CA. Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom synthesis for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the U.S., the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership. Bachem. Pioneering Partner for Peptides Your Responsibilities The Quality Assurance Specialist II fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training . Your Tasks • Review validation protocols, data and reports, as assigned • Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls • Perform annual product quality reviews and system reviews as assigned • Review raw material records • Provide support to customer and regulatory audits. • Conduct internal audits as assigned • Implement improvements in quality systems and SOPs • Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control • Provide technical assistance on all production & quality systems documents • Organize and update document room files as required • Assist with ad hoc QA projects and other duties as assigned Your Profile • A Bachelor's Degree in Science or related field and a minimum of 3 years' experience in the GMP / Manufacturing setting or • Associates Degree in Science or related field and a minimum of 5 years' experience in the GMP / Manufacturing setting • 3 years' work experience in GMP manufacturing • Experience in GMP manufacturing, Quality Assurance and/or Quality Control • Experience with GMP document control, validation, qualification and calibration • Ability to work in ISO7 and ISO8 control environment and support real time batch record review • Experience in internal auditing as well as working with regulatory agencies • Excellent written and oral communication skills • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. • Detail oriented with the ability to troubleshoot and resolve problems • Ability to work independently and manage one's time • Communicate effectively and ability to function well in a team environment We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego

Keywords: Bachem, San Diego , QA Specialist II QA BSD, Other , Vista, California

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