Quality Control Manager, QC Labs
Description
Millipore (NYSE: MIL) is a Life Science leader providing cutting-edge technologies, tools and services for bioscience research and biopharmaceutical manufacturing. Since its founding in 1954, Millipore has expanded its capabilities through strategic acquisitions, targeted capital investments, and organic growth.
Today we offer an extensive portfolio of products and services in: Life Sciences, Drug Discovery and Development, Lab Filtration, Lab Water, Upstream Bioprocessing, Downstream Bioprocessing and Process Monitoring. Millipore revenues reached $1.6 billion in 2008, our global customers include, Private research institutions, Analytical, academic and clinical laboratories and Biotech, pharmaceutical and contract manufacturing organizations. In addition to its headquarters in Billerica, Massachusetts, Millipore maintains subsidiaries or offices in more than 30 countries and a vast network of distributors and dealers. Millipore’s major manufacturing centers are based in Molsheim, France, Cork, Ireland and Jaffrey, New Hampshire.
Our major research and development center is located in Bedford, Massachusetts. Millipore employs approximately 6,000 worldwide with 2,800 in North and Latin America, 2,700 in Europe, and 470 in the Asia-Pacific region.
Position Title: Quality Manager, QC Laboratories
Position Summary:
Responsible for managing the development, implementation and maintenance of quality assurance systems and activities related to multiple site QC Laboratories and Environmental Monitoring of controlled manufacturing environments.
Key Responsibilities:
Responsible for managing the day-to-day operatons of Jaffrey, NH and Bedford, MA QC laboratories. Responsible for the integrity of lab test methods and practices; compliance with Millipore Quality Management System and regulatory requirements (i.e. cGMP, ISO quality system elements); and adherence of all lab activities to the highest standards of ethics. Responsible for prioritizing testing and other work in the QC laboratories to meet business demands. Responsible for maintaining adequate resources, staffing coverage, equipment and supplies for the lab to perform its essential functions including environmental monitoring. Responsible for communicating with appropriate functions (e.g. Operations, Pilot, R&D) on issues regarding testing capacity and timelines to ensure the adequate throughput and prioritization in the labs. Responsible for the oversight, guidance, and staff development of the QC laboratory personnel .Responsible for providing technical and quality guidance for issues related to the QC laboratories and environmentalmonitoring of controlled manufacturing environments. Responsible to manage lab-specific projects, working with area management and internal stakeholders to achieve set timelines. Responsible for effective communication of significant issues with management in a timely fashion. Demonstrated effective communication to include issue identification, business impact, and recommendations for next steps towardresolution. Responsible for providing input to the annual budget process, managing Jaffrey-Bedford lab expenses to achieve financial targets and control expenses. Anticipates, recognizes and controls safety hazards and environmental impacts associated with job function (e.g. identifies risk reduction and waste elimination opportunities, reports all incidents and near misses, completes all EHS related training, wears proper Personal Protective Equipment).
Exhibits the following leadership competencies: communicates effectively, learns from experience, drives innovation, takes global perspective, action oriented, sees beyond own function, encourages process improvement, develops people, prevents complacency.
Qualifications:
BS Microbiology/Biology or related science and minimum of five years of direct Life Science industry experience is required. Advanced degree is desirable. A minimum of 5 years direct Biology/Microbiology or related science laboratory management experience is required. Knowledge and application of FDA regulations and ISO requirements pertaining to pharmaceutical or medical device manufacturing, lsterilization, and environmental monitoring and control is required. Experience in membrane and/or filter device manufacturing is desirable. Experience in laboratory environments compliant with Good Laboratory Practices (GLP) is a plus. Knowledge of biocompatibility and shelf life testing requirements is desirable.
https://millipore.taleo.net/careersection/2/jobsearch.ftl?lang=en&portal=101430233
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