Quality Assurance Specialist (GMP)

 

Work Your Magic with us!  

 

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:

As a Quality Assurance Specialist at MilliporeSigma, you will ensure that all aspects of product release meet specifications in accordance with all established quality systems. You will support the maintenance, development, and improvement of GMP and/or ISO-9000 quality systems, such as auditing (internal, supplier, and customer), training, change control, complaint handling, and documentation control.  You will represent the site during customer audits and regulatory inspections and stay up to date on regulatory requirements, as well as company quality policies.

Responsibilities:

• Improve quality systems in both GMP and non-GMP production environments
• Drive quality improvement in multiple departments
• Communicate the status of operations and bring critical deviations to the attention of your manager
• Communicate with coworkers and interact with other departments on a regular basis
• Complete and have accurate work consistently within quality guidelines
• Take note to details and ensure others do as well
• Assist in maintaining department KPIs through on time CAPAs, Deviations, Complaints and Change Controls
• Assist in compliance with Life Science and site quality policies and procedures
• Represent the site during customer and regulatory audits
• Perform internal audits
• Assist in the investigation of customer complaints

 

Who You Are:

Minimum Qualifications: 

• Bachelor’s degree in Chemistry, Biology, or other science discipline
• 1+ year of work experience in a GMP manufacturing or testing facility

 

Preferred Qualifications:

• Master’s degree in Chemistry, Biology, or other science discipline
• 3-5 years of work experience in the Quality field
• Experience with quality management systems such as Trackwise, electronic document management, etc.
• Ability to multitask and prioritize
• Strong oral and written communication skills
• Understanding of ISO and cGMP quality standards
• Ability to solve problems and coach others in problem-solving situations
• Computer literacy, including Microsoft Word and Excel

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