JOB REQUIREMENTS: Work Location: Sheboygan Falls, Wisconsin Shift: No Department: LS-SC-PMSK1 Quality Recruiter: Michelle Cole This information is for internals only. Please do not share outside of the organization. Your Role 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 discipline * 3+ years of experience with quality assurance and quality management systems * 3+ 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 The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination . ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/? did=YmJnZW5lcmljLjUzMzkzLjg3NzBAZW1kbWlsbGlwb3JlY29tcC5hcGxpdHJhay5jb20