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    Supervisor, Quality Assurance - Cincinnati, United States - Merck Group

    Merck Group
    Merck Group Cincinnati, United States

    2 weeks ago

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    Description


    As the Quality Assurance Supervisor, you are a leader for the Quality Assurance team at MilliporeSigma Norwood, reporting to the Quality Manager.

    The QA Supervisor is the driving force behind the site's commitment to the ISO 9001:2015 Quality Management System (QMS) standard, as well as Life Science Divisional Quality System requirements.

    Provide expert guidance in resolving complex quality issues, ensuring compliance with rigorous site standards Lead and inspire a high-performing team of 2-3 professionals, driving compliance with applicable standards, regulations and company requirements, and exceeding quality expectationsNurture a dynamic quality culture within the team, fostering continuous improvement and ensuring adherence to standards and best practicesProactively monitor and analyze metrics and key performance indicators (KPIs) related to Quality at the site, identify positive and negative trends, and implement data-driven strategies for enhanced quality outcomesEnsure critical investigations are completed successfully and according to established protocols; lead or assist in conducting in-depth analyses of out-of-specification (OOS), Corrective and Preventive Action (CAPA), Complaint, Deviation, Change Controls, and Root Cause Analysis (RCA).

    Lead internal ISO 9001 QMS audits and actively participate in external audits, leveraging expertise to ensure compliance with regulations and customer expectations/requirementsProvide QA information and support for new product introductionsRespond to QA-related customer questionsWork with the QA team to write, review, and approve Operating Procedures, Work Instructions, and Forms for the QA group, and to provide Quality assistance/input to other departments as they develop their documentationAct as the primary point of contact and site expert for the document control systemAct as the primary point of contact and site expert for the Supplier Quality Management systemMonitor the production floor, QC labs, and DC warehouses for any quality-related issues, taking prompt action and collaborating closely with stakeholders to swiftly resolve issuesLead or assist (as applicable) process improvement initiatives and projects, leveraging your expertise to drive continuous improvement of quality-related practices, methods, and systems Who you are:

    Minimum Qualifications:
    Bachelor's Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biotechnology, etc.) or a Bachelor's Degree in an engineering discipline (e.g. Chemical, Process, Mechanical, etc.)5+ years industry experience2+ years leadership or management experienceORMaster's Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biotechnology, etc.) or a Master's Degree in an engineering discipline (e.g. Chemical, Process, Mechanical, etc.)
    2+ years industry experience2+ years leadership or management experience Preferred Qualifications:

    • Knowledge/Experience with ISO 9001ISO 9001 Lead AuditorTrackWise, SAP and Document Control experienceSupplier quality management experienceExperience communicating across all levels of an organization, and with customersExcellent writing skills and experience writing technical documentation and reportsAbility to manage multiple projects/tasks/priorities simultaneouslyExcellent problem solving and time management skillsKnowledge of data analysis, presentation, and experimental designHigh level of proficiency in Microsoft Office suite programs and the ability to learn new software
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