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 Quality Assurance (QA) Senior Associate position at MilliporeSigma in Madison, WI is a critical part of the Quality Assurance Operations (QAO) team and will perform data and batch review, document control and auditing, and support data integrity and root cause analysis. The QA Sr. Associate is responsible for guidance and coaching during operations, as well as assessing and auditing manufacturing processes in real time, providing immediate review with constructive feedback. The ALCOA+ attributes are reinforced by having QA staff on the manufacturing floor. Additional responsibilities include the following:
Act ethically and ensure quality of own work and that of othersEnsure turnaround times are met by working with cross-functional teams and building networks within QA Operations and other departmentsBatch review and release Preparation of documentation for production execution including batch records, supplemental logs, packaging and shipping and other documents in support of cGMP operationsProvide a presence in the Production, Quality Control and warehouse areas to review paper or electronic documentation and to perform line clearances and QA checksReview batch records in a timely manner to meet committed release dates and ensure documentation is attributable, legible, traceable, permanent, contemporaneously recorded, original and accuratePrepare certificates of analysis and batch release documentation for accuracy and completion prior to final release of productProduct release through the review of batch documentationProvide ownership of RFT metrics and QAO KPIsConduct internal audits and self-inspectionSupport the DI assessment program
Who You Are
Minimum Qualifications:
Bachelor’s Degree in Biology, Chemistry, or other Life Science discipline
OR
High School Diploma or GED3+ years of GMP experience
Preferred Qualifications:
Basic knowledge of FDA regulations (21 CFR Parts 11, 210, 211 etc.)Experience in Quality Assurance field within a GMP environmentFamiliarity with International regulations (EMA, MHRA)Strong oral and written communication and interpersonal skillsOpen-minded, flexible, and capacity to work with agility
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