Sr Quality Control Supervisor I, II

Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.Berkeley, California is a multi-functional Bayer HealthCare site that houses the global headquarters for the Specialty Medicine business units, the headquarters of the global biotech product supply organization, and one of three major global R&D sites focusing on protein therapies. In fact, Berkeley is essentially the nerve center of Bayer HealthCare's biotech operations. With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.POSITION DESCRIPTION-Prepares budgets for area of responsibility, obtains approval and ensures budget adherence, is authorized to approve expenditures based on guidelines. -Plans and organizes cross-functional activities. Participates in human resources issues and is responsible for performance management in area of responsibility. -Continuously participates in technical and non-technical training. -Responsible for HES, safety and quality compliance. -Supervises or oversees shift(s) / smaller operation and/or project / assignment including safety, regulatory and environmental compliance. -Assures continuous improvement of processes.-Resolves inter/intra-departmental technical and administrative conflicts.-Demonstrates high level of urgency and adapts to changing priorities.-Typically involves more complex manufacturing supervision scope / responsibility.-Provides technical / non-technical report status on budgets and schedules.-Provides review of test records, test results, and excursion reports to operations and QA in timely manner-Partnering with operations and QA for performing facility monitoring and assessment.-Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.-Interacts outside the technical area with Administration & Human Resources Departments and counterparts in Bayer AG.-Solidifies formulation of career plans.-Utilizes flexible leadership skills.-Demonstrates integrity and a firm commitment to company beliefs and values.-Provide technical expertise to prevent contaminations.-May include staff reporting to this position. POSITION REQUIREMENTSPHD in a Life Science degree with minimum of 2 years relevant experienceMS in a Life Science degree with minimum of 4 years relevant experienceBS in a Life Science degree with minimum of 6 years relevant experience, or equivalent combination of education and experience.Degree must be in a relevant discipline: Biology, or other Life Sciences, etc., plus the appropriate number of years of relevant experience in a Quality environment with experience in the biopharmaceutical industry preferred. Must have experience and accomplishment in laboratory testing that includes one or more of the following test methods: RIA, EIA, ELISA, Tissue Culture, Coagulation, Blood Banking, and Anticomplement testing. Must be familiar with GLP/GMP rules and regulations.Experience with equipment troubleshooting. Excellent written and verbal communication skills required.Working familiarity with Microsoft Word, Excel and Access required. Ability and initiative to work with minimal supervision require-Experience in Enviromental monitoring and Utilities-Knowledge of Compendial requirements for EM program- Aseptic guidance document, USP, EU annex, ISO 14644, cGMP, CFR -Experience with EM/utility monitoring equipment and methods-Knowledge of EM Scheduling and LIMS-EM data trending, analysis and conclusion-Familiar with Risk analysis and Risk management ICH Q9-Experience with facility and utility qualification..