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Job Field: Legal Jobs
Location: Berkeley, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Bayer HealthCare is a leading global specialty pharmaceutical and biotechnology company, and the San Francisco Bay Area is home to more than 1,800 employees focused on the research, development and manufacture of biologics. At Bayer''s Berkeley campus, employees ensure clinical manufacturing and process development of new protein worldwide. A second supply center is located in Emeryville where Bayer manufactures one of the first biologic therapies introduced for the treatment of multiple sclerosis and safely used by patients in more than 100 countries for nearly two decades. Our Sunnyvale location is part of the Bayer Diabetes care group. Discovering novel new medicines is the mission of Bayer scientists. Mission Bay is home to Bayer''s new U.S. Innovation Center where scientists working in the fields of biologics and hematology research reach out and collaborate with academic institutions and small life science companies with the goal of improving patient care and patient outcomes. FFP Conformance We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.To all recruitment agencies: Bayer does not accept unsolicited third party resumes.Sr. Product Specialist. The person is needed to investigate and resolve discrepancies that occur in the production environment. Analyze and evaluate interactions between potential causes, test results, process/equipment changes, and process variables to identify root cause and corrective/preventative actions. Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement. Determine the breadth of discrepancies and insure appropriate Stakeholders in other organizations are made aware of a potential similar issue in their area. Write concise, accurate and effective discrepancy reports that meet compliance expectations. Generate appropriate written documentation to support rationale/justification for decisions made regarding potential impact/risk and product disposition. Influences direction of investigations and communicates with all levels of employees. Use the Discrepancy Management system/database at an expert level to perform data entry and data-mining, in the support of both investigations and report-outs. Maintain Conformance KPI information, FPM QMR information, and FPM Process Review information. Minimum education: B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc. Minimum experience: BS 6+ years or MS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry, or an equivalent combination of education and experience. Experience in performing investigation type work. Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems, etc. Experience with regulatory and cGMP requirements for pharmaceutical manufacturing. Strong analytical skills to identify root

KEY REQUIREMENTS:

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