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.
Collaborate with internal teams to develop, improve, and execute processes within ISO 9001 and ISO 13485 quality systems.Drive and implement quality improvement initiatives across all departments.Ensure the timely completion of tasks and maintain accurate records according to quality guidelines.Communicate operational status and critical deviations to management, fostering inter-departmental collaboration.Support department KPIs by assisting with on-time CAPAs, Deviations, Complaints, and Change Controls.Help ensure compliance with Life Science and site quality policies, including representing the site during audits.Manage documentation control activities, including electronic systems, and contribute to controlled document creation and review.
Physical Attributes:
Environmental conditions: Varies depending on specific job responsibilities.70-100% Office Environment, 10-30% On-the-floor QA activities/observation.Physical requirements: Give site tours of facilities including use of stairs.
Who You Are
Minimum Qualifications:
Bachelors Degree in Biology, Process Engineering, or other Life Science or Engineering discipline and 3+ years of life science industry experience.
OR
Bachelor’s degree and +5 years applicable Quality System (i.e., ISO environment) experience in the specific QA job function.
Preferred Qualifications:
Degree in Biology, Process Engineering, or other Life Science or Engineering discipline and +2 years in industry experience.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 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!