Senior Associate Analytical Validation Specialist
Millipore Corporation

The Senior Associate Analytical Validation Specialist at MilliporeSigma will support plans to validate analytical methodology and instrumentation according to customer and/or internal policy, support, monitor, and report actualization of the plan, and complete all necessary documentation required to realize the maximum value of the resulting information. Additional responsibilities include the following: * Ensure that all change management requirements are followed per company policies and procedures* Request necessary resources and support project team development, which could include analysts, metrologists, production staff and project managers* Work with local management to meet or exceed all established deadlines* Report study results within MilliporeSigma validation team* Assist internal groups to identify methods and processes in need of validation, including analytical methodology as well as instrument and method comparison studies and instrument initiation/operation qualification* Take a proactive role maintaining site validation policies and SOPs to meet industry standards and company policies* Contribute to the content creation for white paper documentation that is presented to customers* When validation is necessary to resolve a quality investigation, support the development and execution of a protocol to guide the investigation, request resources to research activities, and provide the statistical analysis reports to support the findings of the experiments* Represent Quality Control in local validation investigations initiated by production or Quality Assurance as needed* Determine the hypothesis and scope of the investigation, as appropriate* Request resources to support the investigation, such as sample analysis and data compilation, which could include support of analysts, metrologists and QC QA Liaisons* Evaluate the results of the investigation and provide conclusions to the investigation team* Support the success of the Long-Term Stability (LTS) program* Understand and support the LTS requirements for customers and internal policy, especially Gage R&R refresh tasks* Request resources to support data acquisition and compilation, including updating control charts, which could include support of analysts and the appropriate QA Liaison* Establish realistic and achievable deadlines for all required work and ensure that the deadlines are being met* Establish new control charts, including selection and validation of monitor parameters* Expand knowledge and application of LTS across new and established measuring systems* Provide continuous technical instruction for the QC department regarding Measuring Systems Analysis (MSA) terms and definitions* Perform other functions and duties that may be assigned by Quality management

Who You Are:

Minimum Qualification:* Associate degree in a Physical Science or Mathematics discipline * 1+ year of experience with analytical methods and/or statistical analysis

Preferred Qualifications:

* Bachelor's degree in Chemistry, Biology, or other Science discipline with a minor in Statistics, or other Mathematics discipline* 1+ year of laboratory experience* Experience performing statistical analysis of analytical results such as: Gage R&R, Linearity, Equivalency, Gross Reality Checks, etc.* 1+ year of experience with statistical analysis software (JMP, R, Minitab, etc.)