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Job #03070

About our client Our client, a privately held pharmaceutical company, is focused on the development and commercialization of innovative therapeutics for the treatment of severe ocular diseases and conditions. Based in California, the company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance Manager Northern California (Central Bay) Salary Highly competitive package, commensurate with experience Responsibilities 1) Evaluate and provide input in developing quality systems 2) Review analytical data HPLC, GC and MS 3) Implement training programs 4) Write quality agreements with external contract manufacturers 5) Review regulatory documents and submissions (as required) 6) Assist in inter-departmental collaboration and guidance to ensure technical evaluations are performed in a timely manner 7) Provide guidance to other members of the QA Group as needed 8) Review and approve GLP data and reports 9) Perform internal and external audits as necessary to support GMP operations 10) Identify quality issues and communicate to manager (as appropriate) 11) Review and revise current SOPs for QA operations (as necessary) Requirements 1) BS in Chemistry or related field, or equivalent preferred 2) 2 – 3 years of experience in quality systems as well as lab experience 3) Strong understanding of GLP/GMP 4) Familiarity with medical and pharmaceutical industry, terminology and practices 5) Proficiency with MS Word, MS Project and Excel