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Quality Assurance Manager/GMP Expert
5 months ago
MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager/GMP Expert. As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies. Responsibilities:Lead a team that manages specific quality management systems and processes such as deviation, CAPA, change control, training, audits, complaint management, supplier quality, document control, validation, and data integrityEnsure that departments responsible for products meet quality standards and performance goals of MilliporeSigmaEnsure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systemsSupport the site's compliance activities through accurate regulatory recordkeeping and reportingManage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMPDrive risk reduction programs and ensure application of risk management and sound root cause analysisSupport the site's regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc. Who You Are: Minimum Qualifications: Bachelor's degree in Life Sciences, Pharmacy, Engineering, or other Science field 5+ years experience with ISO 9001 and GMP requirements in a quality role inclusive of 2+ years experience in a leadership positionExperience in a chemical, specialty chemical and/or pharmaceutical industry Preferred Qualifications:8+ years of experience with ISO 9001 and GMP requirements in a quality role in a chemical, specialty chemical and/or pharmaceutical industry3+ years of experience with increasing responsibilities as a people managerExperience with quality management systems such as Trackwise, electronic document management system, etc.Experience with customer audits and regulatory inspections
