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 Quality Assurance Specialist 3, Quality Systems and Product Support role is to manage the implementation and maintenance of quality systems and ensure MilliporeSigma's compliance with government regulations by coordinating with suppliers and customers to develop consistent and efficient business practices. The Quality Assurance Specialist 3 is the first point of contact for managing internal and external nonconformities. Responsibilities focus on enhancing the Lenexa Dry Powder Media manufacturing site by providing expertise in advanced problem-solving and implementing corrective and preventative actions by collaborating closely with internal team members, stakeholders, collaborators, and participating facilities.
Review controlled documents to ensure GMP and procedural compliance
Support all product quality-related changes to training curriculums, documents, equipment, specifications, and methods.
Investigate nonconformities (Deviations) and manage Corrective and Preventative actions
Preparation of confidential and proprietary documents and agreement
Serves as an operational resource in the analysis of risk for adverse events through the root cause analysis process using performance improvement tools and methodology
Drives expedited problem identification and resolution, provision of RCA-specific updates, and team interactions and deadlines driven by product release
Site lead user for Quality Management System
Support the development of project plans for specific quality system initiatives and process improvements
Maintains current understanding of quality systems for business units including DPM (Dry Powder Media products) and applies and interprets regulations in making business decisions and risk assessments
Utilizes project management tools and methodologies to track and communicate the status of RCA and provides regular updates to the RCA Teams, ensuring the team is informed of status updates of the root cause analysis
Demonstrates leadership in developing and implementing quality system initiatives in areas of Operations and Product Support
Establishes and maintains collaborative relationships within the system to foster successful root cause analysis completion
Lead change team assessment of end-to-end impact for product, process, systems, assay/method, and equipment change controls
Develops and manages best practices and tools for improvement, plan execution, and project management
Ensure personnel are treated with respect and dignity with an emphasis on providing a strong avenue for communication and company values
Who You Are
Minimum Qualifications:
Bachelor's Degree in Chemistry, Biology, or other Life Science discipline
6+ years of experience in Quality Assurance in a GMP environment
OR
Bachelor's Degree in any non-Life Science discipline
9+ years of QA experience in a GMP or ISO environment within the pharmaceutical or healthcare industry
Preferred Qualifications:
6+ years of experience with quality assurance in Pharmaceutical or Biopharmaceutical with demonstrable familiarity with cGMPs, cGLP's and/or ISO requirements
Thorough understanding of ISO 9001:2015, EXCiPACT, and GMP guidelines
Green Belt certification
Quality Auditor Certification
Highly refined written and verbal communication skills
Ability to organize tasks effectively with good time management and multi-tasking capabilities
Ability to lead multi-functional teams & implement project initiatives
Exceptional critical thinking skills with the propensity for making good risk-based decisions based upon a mixture of analysis, experience, and judgment promptly
Working knowledge of computer programs such as TrackWise, SAP, and BPCS, in addition to Microsoft Office
Consensus builder among teams and cross-functional groups with differing objectives and priorities
Excellent interpersonal skills for interacting with many internal departments and management levels, along with customers, suppliers, and regulatory authorities
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