Quality Assurance Specialist

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:

A great opportunity has opened as a Quality Assurance (QA) Specialist at our Round Rock location. In this role you will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements. Specific job duties include:

• Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods
• Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy
• Generating and review Certificate of Analysis (CoA) for catalog and custom projects
• Assist in preparation and hosting external audits including customer, ISO, and DEA audits
• Generate quarterly metrics summarizing documentation review and production activities
• Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements
• Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents
• Assist with internal audits as needed to maintain audit schedule
• Support rollout of local and corporate initiatives

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline

       OR

• High School Diploma or GED
• 5+ years of experience in an ISO environment

Preferred Qualifications:

• Working knowledge of quality system requirements of the pharmaceutical and/or clinical industries
• Prior work experience in an ISO, or similarly regulated environment
• Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001
• Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts
• Ability to communicate effectively with all levels within the organization and with outside contacts
• Self-motivated with the ability to work independently
• Ability to critically review documents for discrepancies with written procedures and requirements

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