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Job #02906

About our client Our client is an acute care specialty pharma company based in San Diego. They specialize in a technology that provides sustained-release delivery of medications for post-surgical pain. Our client has two marketed products that are used by professionals in the healthcare industry. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Senior Quality Assurance Manager San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all support investigations for incident reports for manufacturing, QC/Micro out-of-specification and out-of-trend test results 2) Handle facilities out-of-limits reports, calibration out-of-tolerance notifications, environmental monitoring action reports and temperature excursions 3) Handle non-conforming material reports and batch failure investigations 4) Propose and approve CAPAs 5) Investigate and respond to product complaints 6) Participate (proactively) and direct batch failure investigations 7) Review and approve all SOPs, engineering/software change requests, validation protocols/reports and engineering drawings 8) Perform and monitor the inspection of labeled vials for accuracy, correctness and legibility 9) Assist with the review of documents and data submitted in or in support of regulatory submissions 10) Maintain QA control of raw material quarantine and raw material reserve samples Requirements 1) BS in Chemistry 2) 10 years of relevant pharmaceutical industry experience 3) Experience in decision processes, problem-solving, root cause analysis and constructive issue resolution 4) In-depth knowledge of cGMPs, EMEA and MHRA regulations and their application 5) Understanding of performing regulatory agencies’ general audits 6) Ability to work successfully in a fast-paced, rapidly changing environment