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Bio-Rad Laboratories - Clinical Diagnostics Group Production Mgr II Job Details

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Job Ref:  R11-027
Job Type:  Full Time
State:  Washington (WA)
City:  Woodinville
Post Code:  Nov 02, 2011
Job Description:  Join us at the forefront of scientific discovery! At Bio-Rad Laboratories, you will participate in exciting new developments at the cutting-edge of science and technology. Our teams of dedicated professionals work together in an entrepreneurial atmosphere, providing a broad range of innovative tools and services to the clinical diagnostics and life science research markets. Bio-Rad was founded more than 40 years ago, and we are recognized as a world leader in science and research. Visit us at www.bio-rad.

JOB RESPONSIBILITIES/REQUIREMENTS:
-Manages the activity of assigned commercial manufacturing functional areas for BioPlex2200 including ME, Production and QC.
-Coordinates department resources including personnel, materials, equipment and facilities to meet the Master Production Schedule (MPS), to support the introduction of new products and processes, and other activities such as budgeting, training, project management and reporting.
-Assures the effective use of resources. Prevents or minimizes customer back orders.
-Provides support for the long term business plan through monthly reporting, specialized reporting, budget revisions and justification documents including personnel requisitions, capital equipment requests and return on investment analyses.
-Hires new personnel, recommends promotions and merit increases, and manages disciplinary actions for assigned areas.
-Assures all assigned personnel receive training in technical job requirements and in safety and Quality System Requirements.
-Establishes and manages departmental budgets.
-Manages business system functions such as work order variance management, capacity reporting and engineering changes for assigned areas.
-Investigates product, process and testing issues as they arise.
-Coordinates reviews of non-conforming material.
-Provides decisions and solutions to problems, obtains support from appropriate resources, and summarizes and reports on results.
-Provides information to cross-functional management teams as input for effective preventive and corrective action decisions.
-Responsible for final product release to finished goods for FDA licensed and 510K products, including management of all systems required assuring full safety and efficacy of product.
-Assures the completion of all required product documentation, including historical tracking of performance data.
-Reviews and implements methods and procedures for inspecting, testing, and evaluating the quality of products.
-Assures adherence to specification of all products produced.
-Participates in the design of tests and experiments for trouble shooting of process problems.
-Identifies and implements methods and systems for cost reduction and process improvements while considering quality and safety requirements.
-Acts as liaison for all audits of functional areas, including FDA, customer, and internal audits.
-Responsible for compliance of assigned areas and implementation of required audit actions.

Requirements

-Bachelor's degree in Biological Science required.
-Knowledge of cost accounting and budgeting methods required.
-7-10 years experience preferably in Biotech or related industry utilizing GMP and working under regulatory guidelines from FDA or similar agencies.
-Must include a minimum of 5 years supervisory or management experience.
-Understanding and comprehension of FDA regulations/GMP, quality systems, and clean room processes.
-Computer software skills required including word processing, spreadsheet, business and data management systems.
-Ability to obtain technical understanding of assigned product lines and applicable production and testing equipment.
-Ability to communicate effectively orally and in writing.
-Demonstrated ability to meet deadlines, make sound decisions quickly, and maintain effective working relationships at all levels of the organization.
-Demonstrated ability to organize work functions and staff assignments, establish responsibility, delegate authority and review the work performance of staff in an effective manner.

EOE

11/03/2011
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