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 Sr. Quality Assurance Associate provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a Sr. QA Associate, you are responsible for the coordination and maintenance of Quality Systems (i.e., Document Control, Record Control, Training Program Maintenance, Deviation/CAPA, Complaints, Change Control) and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.

· Improve quality systems in ISO production environments.
· Documentation control activities include management of the electronic documentation management system, and the ability to write, review or approve Operation Procedures, Specifications, Master Manufacturing & Packaging Procedures and other controlled documents.
· Training Management coordination including metric reporting and management of the electronic training platform.

· Complete a high volume of work to meet department goals.
· Communicate with coworkers and interact with other departments on a regular basis.
· Complete and have accurate work consistently with quality guidelines.
· Assist in maintaining department KPIs through on time CAPAs, Deviations, Complaints and Change Controls.
· Assist in compliance with Life Science and site quality policies and procedures.
· Assist and/or act as Lead Auditor in conduction internal audits.
· Assist in the investigation of customer complaints.
· Contribute to Root Cause Investigations & Effectiveness Checks of Nonconforming Incidents.
· Conduct Quality System Training specific to job function.

- This individual will work with various internal departments to develop, improve, and execute processes used in an ISO 9001 and ISO 13485 quality system environment.

ADDITIONAL LOCAL NEEDS:

· Environmental conditions: Varies depending on specific job responsibilities.
· 70-100% Office Environment, 10-30% On-the-floor QA activities/observation.
· Physical requirements: Give site tours of facilities including use of stairs.

Who You Are

Minimum Qualifications:

· Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering

· 0-2 +years’ experience in industry.

OR

 · An Associate degree

· 5+ years experience in a QA job function as deemed appropriate by QA Management, or 5+ years’ industry experience with a degree not specified in a Life Science.

Preferred Qualifications:

· Knowledge of ISO 9001 required.
· Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.
· Current fine chemical industry knowledge &/or experience.

RSREMD

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