Senior Quality Assurance Representative

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.  

Your Role:

This role provides weekend shift (Friday - Sunday) support as the primary quality assurance on-the-floor oversight for manufacturing activities at the facility, with the availability to flex to weekday shifts for training activities. There are multiple QA floor support representatives supporting manufacturing so that manufacturing activities on each shift are covered.

Responsibilities include but are not limited to:

• Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed
• Performs and documents line clearances and room release for manufacturing use
• Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented
• Monitors the formulation and filling processes to ensure cGMP compliance
• Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators.  Requires qualification in aseptic gowning and certification as an aseptic processing SME
• Observers, reports, and documents operator cleaning and disinfection practices
• Documents, reports, and trends observations stemming from Quality Oversight
• Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices
• Partners with manufacturing supervision to immediately address and develop plans of action for deficiencies observed in manufacturing operations or the manufacturing facilities. Deficiencies include any GMP violations, unsafe conditions, improper aseptic practices or other unusual results or practices
• Escalates significant issues immediately to Quality Assurance management
• Performs document revisions, deviation reviews, and processes change controls in existing Quality Systems
• Provides training to operations personnel in areas such as FDA requirements, good documentation practices, contamination prevention, and housekeeping
• Serves as a resource during investigations of deviations and unexpected events.  This includes interviewing operators and providing first-hand accounts of operations observed

Physical Attributes:

• Lift and/or move up to 25 pounds

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience

OR

• High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience

Preferred Qualifications:

• Experience computer software applications including Microsoft Excel, Word, and Access
• Experience with Quality Management computer systems and SAP
• Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning

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