Senior Quality Assurance Specialist

Work Your Magic with us!

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 opportunity is within the Quality Assurance Systems group at the MilliporeSigma St. Louis Cherokee site. The Senior Quality Assurance Specialist will have a science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on Quality Management Systems. Job duties will include:

• Represent QA to customers, internal stakeholders and other site projects as assigned.
• Review of data, documents, and other quality records for compliance in meeting product, system, and regulatory requirements; specifically in facility, process, equipment, and computer systems validation.
• Management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, and internal auditing.
• Working with appropriate internal and external stakeholders to identify and resolve quality risks, problems, or concerns.
• Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
• Support and train on Quality Management Systems as needed.
• Work with QA and/or other process or business leaders on urgent/critical activities or corrective actions needed for the business.
• Work cross-functionally to make improvements to the Quality System and ensure compliance with Policies & Regulatory Guidelines, including Design Control, CAPA, Nonconformance Systems, Process Controls, Management Controls and other QMS sub-systems.

Who you Are :

Minimum Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, Biology, or life science discipline.
• 5+ years of GMP quality experience in a biologic, Active Pharmaceutical Ingredient, or Drug Product manufacturing environment

Preferred Qualifications:

• Ability to work and communicate well with other key groups to achieve improvement and operational results.
• Good working knowledge of cGMP and regulatory standards as they pertain to Drug Product and/ or API manufacturing.
• Experience with data integrity program as it applies to cGMP's.
• Demonstrated experience in detailed review work and following procedures, especially in a GMP regulated industry.
• Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ICH Q7, 21 CFR Parts 210 and 211
• Experience in technical review of documents pertaining to various GxP systems
• Good oral and written communication skills.
• Good evaluation and analytic skills for problem identification and communication to others.
• Demonstrated knowledge and experience in various computer skills, including, Word, Excel, and Outlook, as well as familiarity working in a windows-based environment.
• Investigational and Root Cause Analysis skills
• Independent, self-starter with proven results in QA processes/Systems.

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