QA Senior Associate
About The Position
The Quality Assurance (QA) Senior Associate position at MilliporeSigma Verona, WI is a critical part of the Quality Assurance Operations (QA Ops) team and will perform data and batch review and release and document control functions. The QA Sr. Associate is responsible for guidance and coaching during operations, as well as auditing manufacturing, quality control, and materials management areas, providing immediate review with constructive feedback. We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!
Requirements
- Bachelor’s degree in Biology, Chemistry, Chemical Engineering, Physics, or other Life Science discipline OR High School Diploma or GED
- 3+ years of GMP experience
Nice To Haves
- Basic knowledge of FDA regulations (21 CFR Parts 11, 210, 211 etc.)
- Experience in Quality Assurance field within a GMP environment
- Familiarity with International regulations
- Strong oral and written communication and interpersonal skills
- Open-minded, flexible, and capacity to work with agility
Responsibilities
- Uphold ethics and quality in own work and that of others.
- Ensure on-time deliverables by collaborating with cross-functional teams.
- Review batch records and related cGMP documentation; generate certificates of analysis and other needed documentation to support batch release.
- Ensure GMP documentation are completed timely, attributable, legible, traceable, complete, and compliant for release.
- Prepare production execution documents (batch records, logs, packaging/shipping) for cGMP operations.
- Own Right-First-Time metrics and QA Ops KPIs; conduct self-inspections and support continuous improvement projects.
- Guidance and coaching during operations.
- Auditing manufacturing, quality control, and materials management areas, providing immediate review with constructive feedback.
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
- other perquisites
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
