Quality Assurance Lead - Membrane Facility

The Quality Assurance Lead - Membrane Facility will lead the development of the QMS and regulatory requirements for the K3 Lateral Flow Membrane facility at MilliporeSigma's Sheboygan Falls, WI site. The QA lead will coordinate with Engineering on the C&Q execution and approval of C&Q protocols and reports and identify, draft, update and implement required Quality Procedures. Responsibilities of this role include the following: Lead the design and setup of the QMS system for the membrane facility. Elements include, but are not limited to; Complaints, deviations and corrective actions Customer notifications SQM Shelf-life elements Business continuity and contingency planning Data integrity Lead general QA functions including; Drive the change control process, including customer qualification Perform risk assessments Provide input and guidance to the validation approach and VMP, including the support in drafting the VMP, validation protocols, and reports Draft, update and implement required quality procedures Ensure environmental controls, monitoring, contamination & pest controls Manage customer audits and visits Prepare, schedule and host internal audits Develop shipping and distribution qualification requirements Support membrane pre-qualification Coordinate the transfer of product specifications and provide support for the preparations and modifications of test methods Perform and oversee test result reviews of raw materials, in-process and final product sample inspections Leverage statistical controls; prepare Statistical Quality Control (SQC) reports Make usage decisions Support the release, storage, distribution, returns and destruction of materials Ensure conformance to MilliporeSigma Quality standards Lead start-up compliance audit and customer audits Perform quality checks and support the data integrity program Who You Are Minimum Qualifications: Bachelor's Degree in a life science discipline3 years of experience with quality assurance and quality management systems3 years of experience in data analysis, descriptive statistics, and data management Preferred Qualifications: Master's Degree in Chemistry, Chemical Engineering, or other physical science discipline Experience in regulated quality environments Strong technical background to interpret complex data Excellent problem-solving and organizational skills Project management skills Knowledge of, and experience with; ISO 9001, ISO 14001, ISO 13845 Knowledge of SAP, JMP, LIMS Risk-based thinking and continuous improvement skills

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