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 provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.
Drive improvements in ISO and non-GMP quality systems, ensuring robust processes and adherence to relevant standards.Champion quality improvement projects across multiple departments to elevate overall product and process quality.Efficiently manage a high volume of work while consistently adhering to quality guidelines and ensuring accurate outputs.Regularly communicate operational status and promptly escalate critical deviations to management for timely resolution.Engage with coworkers and other departments to ensure seamless collaboration and alignment on quality objectives.Contribute to maintaining key performance indicators by ensuring timely completion of CAPAs, Deviations, Complaints, and Change Controls.Assist in maintaining compliance with Life Science regulations, site quality policies, and procedures, and support audits.Participate in internal audits, customer complaint investigations, root cause analysis, effectiveness checks, and conduct quality system training and document control activities.
Who You Are:
Minimum Qualifications
Bachelors Degree in Chemistry, Biochemistry, Biology, or Life Science discipline.3 + years’ experience in Quality System (i.e., ISO environment) experience in QA job function.
Preferred Qualifications
Master’s Degree in Chemistry, Biochemistry, Biology, or Life Science discipline.Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.Current fine chemical industry knowledge &/or experience.Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.).Excellent communication (verbal & written) and customer services skills.Good writing skills and experience writing technical documentation & reports.Ability to simultaneously manage multiple tasks/priorities.Good problem-solving skills/abilities.Good time management and negotiating skills.Capacity for independent work.
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