Senior Quality Assurance Specialist

Work Your Magic with us! Start your next chapter and join Millipore Sigma.

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.

At Millipore Sigma, 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.

• Management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, and internal auditing.
• Review of data, documents, and other quality records for compliance in meeting product, system, and regulatory requirements; specifically in the area of facility, process, equipment, and computer systems validation.
• 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.
• 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.
• Represent QA to customers, internal stakeholders and other site projects as assigned.
• Work with QA and/or other process or business leaders on urgent/critical activities or corrective actions needed for the business.
• Support and training on Quality Management Systems as needed.

• Bachelor's Degree in Science (Chemistry, Pharmacy, etc.) or Engineering (Chemical, Process, etc.).
• 5+ years of quality experience in a biologic, GMP, or Active Pharmaceutical Ingredient manufacturing environment.

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

RSREMD

• Pay Range for this position: $62,600.00- $93,900.00.
• The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
  
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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!