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Matt Turner 858.356.6772 posted a job: I'm hiring for this QA TECHNICAL MANAGER position - it's a great place to work - spread the word! "QA TECHNICAL MANAGER in Santa Ana, CA QA TECHNICAL MANAGER Simply Biotech specializes in recruiting exclusively for the biotech community. We are currently seeking a QA Technical Manager for a leading and growing Orange County firm. The QA Technical Manager, Quality Validation is responsible for partnering with the Validation and other technical departments in the initiation, execution, and reporting of validation and qualification projects. This person will participate as a Quality representative in change control activities related to GMP systems, facilities, processes, and equipment and provides quality input for the generation, review, and approval of validation and qualification protocols and reports. The selected candidate may lead investigations and resolve potential product quality issues to improve process effectiveness and reproducibility. This person will further: * Develop, implement and maintain quality assurance systems and activities. Oversee generation and review of documents used in cGMP operations. * Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and company standards * Perform assigned tasks and work to achieve company goals and department objectives. * Select, develop and evaluate personnel to ensure the efficient and compliant operation of the function.es: * Maintain a state of inspection readiness. * Collaborate with Management to establish and meet targets and timelines. * Support routine operations and allocate assigned resources. * Manage competing priorities. * Serve as the Quality representative on cross-functional and multi-site teams. * Identify, design, and implement process and system improvements. * Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems. * Serve as a Quality subject matter expert (SME) in support of department functions. * Train personnel and internal customers on relevant business processes. * Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. * Represent Quality Assurance on multi-disciplinary project teams. * Provide technical assessment and approval for controlled document changes. * Participate in inspection preparation activities. * Participate in deviation investigations and ensure deviations are thoroughly identified, defined and properly assessed. * Interact with interdepartmental contacts on deviation assessment, resolution, and quality approval. * Ensure that the proper policies and procedures are in place. * Identify, design, and implement process improvements. * Provide input into the design and presentation of departmental performance metrics. The QA Technical Manager will possess the following qualifications: * B.A. or B.S. degree (preferably in Life Science) and at least seven years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience * Sound knowledge of cGMPs or equivalent regulations * Ability to interpret and relate Quality standards for implementation and review * Ability to make sound decisions about scheduling, allocation of resources, and managing priorities * Ability to communicate clearly and professionally both in writing and verbally * Flexibility in problem solving, providing direction and work hours to meet business objectives For immediate and confidential consideration, please email your resume to mturner@simplybiotech.com cal... http://bull.hn/l/KKWD/1" |
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Saturday, May 12, 2012
New job I'm hiring for this QA TECHNICAL MANAGER position - it's a great place to work - spread the word!
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