Senior Associate Analytical Validation Specialist

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

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.)

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html