Quality Assurance Senior Associate 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:

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 and specific business-related initiatives.

·       Evaluate raw materials and final products to ensure compliance with import/export regulations, especially those involving animal by-products (ABP).

·       Ensure all products meet analytical, packaging, and labeling specifications aligned with quality and regulatory standards.

·       Act as a technical expert for risk assessments (e.g., pathogens, GMOs, solvents, heavy metals) across the supply chain and report findings.

·       Conduct inspections and make usage decisions on critical raw materials based on current specifications.

·       Lead product-specific quality improvement projects focused on enhancing customer satisfaction and product integrity.

·       Perform batch reviews and ensure supply chain traceability and vendor compliance meet product quality requirements.

·       Conduct internal audits, deliver training, and support ISO 9001/13485 compliance through quality system maintenance.

 Physical Attributes:

·       Environmental conditions: Varies depending on specific job responsibilities.

·       70-90% Office Environment, 10-30% Production, QC, Packaging.

Who you are

 Minimum Qualifications:

·       Bachelors Degree in Biology, Chemistry, Chemical Engineering, or other Life Science, Physical Science, or Engineering discipline and 2+ years of work experience in the pharmaceutical or biotechnology industry. 

OR 

·       Associates Degree in Biology, Chemistry, Chemical Engineering, or other Life Science, Physical Science, or Engineering discipline and 5+ years of Quality Assurance work experience in the pharmaceutical or biotechnology industry.

OR

·       Bachelors Degree in any discipline and 5+ years of work experience in the pharmaceutical or biotechnology industry. 

Preferred Qualifications:

·       Knowledge of ISO 9001:2008, ISO 13485.

·       Knowledge of other regulatory requirements (i.e., USDA, FDA, EC, DEFRA, ICH, and EDQM). 

·       Knowledge of animal/human pathogens.

·       Knowledge of transgenic plant and animal.

·       Current fine chemical industry knowledge &/or experience. 

·       Knowledge of Trackwise, SAP – Resource Planning (ERP) Business tool related to COA generation and release of products.

RSREMD 

What we offer: 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!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!