Quality Assurance Specialist
Millipore Corporation

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:

As a Quality Assurance Specialist in Madison and Verona, WI, you will be providing compliance oversight across the Millipore Sigma Quality Management System (QMS) in collaboration with site personnel. A QA Specialist within the Compliance team provides broad compliance support to cross-functional teams in support of the following: quality management systems or processes such as deviation management, CAPA management, change control, risk management, data integrity, quality management and annual product reviews, supplier quality management, quality agreements, training, field corrective actions, coordination of and participation in regulatory and customer audits, complaint management and divisional policy implementation and compliance. In addition, the QA Specialist will be responsible for collaboration with the site personnel for ensuring that the site is in a continuous state of inspection readiness. This position will use highly developed written and verbal interpersonal skills as they will be representing the Quality Assurance department and will be creating and updating the standard operating procedures ("SOP").

• Establish collaborative relationships with all departments within the organization to deliver on timely quality performance metrics within the QMS
• Lead process control and monitoring of CTQ parameters and specifications
• Lead the investigation, resolution, and prevention of product and process non-conformances
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• Lead in the completion and maintenance of risk analysis
• Work with design engineering in the completion of product verification and validation
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS)
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Identify and implement effective process control systems to support the development, qualification, and manufacture of products to meet regulatory requirements
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Who you are:

Minimum Qualifications:

• Bachelor's Degree in Engineering, Quality Management or Business Quality Management
• 2+ years of Quality Assurance experience working in a GMP Pharmaceutical environment
• 2+ Years of Quality Systems experience in disciplines such as change control, deviations, CAPA's, APR's, auditing, validation, auditing, Supplier Quality, and training

Preferred Qualifications:

• Detailed knowledge of cGMP and site quality systems while collaborating in a matrix environment
• 5+ years of Quality Assurance experience working in a GMP Pharmaceutical environment
• 5+ Years of Quality Systems experience in disciplines such as change control, deviations, CAPA's, APR's, auditing, validation, auditing, Supplier Quality, and training
• Experience in leading and implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• ASQ, CQE, or other Quality-related certifications
• Demonstrated experience in process optimization and/or improvement
• Validation experience in a regulated manufacturing industry

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

This job has expired.