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
Mirus Bio is expanding and has an immediate opening for a Quality Assurance Specialist to perform document control and quality assurance review of the Mirus Bio product portfolio to maintain a high level of quality and performance. The responsibilities outlined below may fluctuate depending on the number of projects and current business priorities.
We are currently on the lookout for a hands-on individual to join our passionate team. If you are someone who thrives in a collaborative, innovative, and fast-paced environment, join us in shaping the future of our industry and be a part of a team that continues to redefine possibilities. This role works cross-functionally with all departments within Mirus Bio.
Assist with revision of all version-controlled documents in the quality systemPerform quality review of labels and data generated by all departments for completeness, accuracy and complianceReview and release raw materials, intermediate products and finished productsCreate and approve of product specific quality documentation such as Certificates of Analysis, Certificates of Origin and product questionnairesAssist with supplier quality including qualifying new suppliers and requalifying current suppliersMaintain training records for all employeesAssist with revisions to quality procedures and process improvementsAssist with onsite audits by customers or regulatory agenciesManage deviations, investigations, change controls and CAPAs to ensure timely closureAssist with review of customer complaints and inquiries as requiredServe as a subject matter expert on Qualio electronic quality management systemPerform quality related activities in Mirus inventory system and temperature monitoring systemsServe as a back-up for various quality responsibilities as neededFollow GMP guidelines and ensure quality compliance Interface and work amicably with other departments including facilities, shipping, production and R&D within Mirus Share information with fellow employeesBuild positive relationships during internal and external interactionsRepresent the company in a positive and professional mannerDemonstrate behavior outlined within the Mirus Bio Employee HandbookPerform other duties as assigned by Sr. Quality Manager
Who You Are
Minimum Qualifications:
Bachelor’s degree in Biology, Chemistry, or other Life Science discipline 2+ years of experience working in a cGMP environment
Preferred Qualifications:
At least 5 years’ experience preferredExperience with quality document reviewWork productively in a team environmentWork in an organized manner, to make critical observations, and to maintain good records of the resultsExcellent verbal and written communication skillsProficiency with Microsoft Office including Excel, Word and PowerPointExperience with maintaining and/or qualifying suppliersExperience or qualification to perform quality auditingPrevious experience working for a life sciences company is preferredExperience with cell biology techniques such as, mammalian tissue culture and transfection
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