Regional Quality Manager- Central

Merieux Nutrisciences Corporation Chicago , IL 60602

Posted 2 weeks ago

This position will be based out of one of our Central laboratory locations and will support the Central region

Job Overview:

The incumbent will assist in the development, maintenance and communication of the company's Quality Assurance system to the network to ensure we are operating within specified quality guidelines. The main purpose of these activities is to ensure that the quality requirements are implemented adequately and the quality system is reviewed, improved and updated. Also to ensure that the in-process reworks are reduced and accuracy of results and customer satisfaction is improved. The incumbent directly reports to the Director of Quality Assurance NA.

Job Responsibilities:

  • In conjunction with technical quality and operations, develop, implement and maintain quality related documents relevant to the NA network.

  • Ensure that the facilities in their region comply with the code of conduct and operate in an ethical and manner maintaining confidentiality and impartiality across all sites at all times.

  • For their region, prepare internal quality audit programs and undertake some of the internal quality system audits for that region.

  • Randomly and systematically verify that the quality system is being followed, effectively documented, and understood by lab facility staff.

  • Where necessary or relevant, monitor the quality activities and ensure that agreed upon corrective actions have been implemented and effectiveness is evaluated.

  • In conjunction with technical quality, ensure the correct implementation of internal quality control programs.

  • Ensure that each facility undertakes effective evaluation of QC data and, where necessary, undertake proper investigations of nonconformance and outliers.

  • Ensure that each facility undertakes effective evaluation of the results and undertakes proper investigations of nonconformance and outliers of QC testing.

  • Ensure that each facility undertakes effective evaluation of PT results and, where necessary, undertakes proper investigations of nonconformance and outliers.

  • Where relevant, perform investigations of quality system failures and make recommendations for correction actions and improvements where necessary.

  • Maintain the external standards and update the method database on an ongoing basis.

  • Where relevant or necessary, participate in client and certification body audits and maintain the approval status.

  • Review and ensure that each relevant facility prepares the information (e.g. internal audit findings, external assessments, quality investigations, quality checks, quality charts, complaints etc.) for the annual MRM.

  • Where necessary and relevant, provide in-house training on the regional and corporate quality system and related issues.

  • Monitor each facility to ensure timely close out of quality investigations, both non conformances and customer complaints.

  • Have oversight of the relevant facility to ensure that they have completed effective root cause analysis, implementation of corrective actions and that follow up has been completed.

  • Routinely prepare a report for management on the status of investigations including status of RCA/CA and follow up.

  • Upon the recommendation of, and in conjunction with technical quality, issue stop work notices when the process is deemed not to be in control or the quality of work could affect the accuracy and reliability of the results. Also communicate such stop work notices as well as the resumption of work to the Regional Head of Operations.

  • Maintain knowledge of LIMS that is required to complete job responsibilities.

  • Perform other related duties as assigned by the Corporate Director of QA for NA and the relevant DVP.

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Regional Quality Manager- Central

Merieux Nutrisciences Corporation