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A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Responsible for providing Quality Operations leadership for the Rocklin site, focusing on the overall Quality release of products.
This role will be responsible for the direct supervision of the Quality Operations team according to established policies and under management guidance. Plan, organize, and supervise activities for the Quality Operations Department and supports the overall Quality organization at the Rocklin site and as directed, within the Life Science organization.
As part of the management team that reports to the Rocklin Site Quality Manager, you would ensure compliance of the QMS in accordance with but not limited to the following standards and regulations - ISO134845: 2016, FDA QSR, IVDD/IVDR, CMDR, ANVISA, TGA. Develop and implement programs to maintain quality standards of products as directed from the site Quality Objectives and initiatives. Review, monitor, and ensure that all deviation, CAPA, MRB and risk assessments are completed and timely per local and global requirements. This role will also provide quality leadership and direction to support business operations. Responsible for ensuring that quality processing of materials meets established timelines and ensures that nonconforming materials are appropriately dispositioned.
Additional responsibilities include but are not limited to interviewing, hiring and training employees, resource planning, assigning and directing work, appraising performance and disciplining employees, responsible for reporting metrics related to quality processing of materials including but not limited to throughput, deviation, and MRB, write, revise and/or review quality system documentation while adhering to regulatory requirements. You may be required to work on various projects to improve efficiency and/or compliance.
This role will require you to be detail oriented and results driven with ability to concisely communicate verbally and written as well as be competent in Microsoft Word, Outlook, and Excel as this role directly support the QC, QA, and QE departments and internal and/or external audits.
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