Quality Systems Specialist 1
Millipore Corporation

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:

As the Quality Systems Specialist 1, you will execute, maintain, and continually evaluate quality assurance functionalities, specifically document control, batch record review, and training. You will support deviation, CAPA, change control, audit, supplier quality, and batch release.

• Maintains the document control system including, but not limited to executing document revisions, managing document workflow in the electronic document system, and maintaining document retention.
• Maintains site training database, which includes entering new training items in system, maintaining curricula, and monitoring and reporting.
• Creation, issuance, review, and maintenance of batch records.
• Executes, maintains, and continually evaluates quality assurance methods and systems and utilizes standards and procedures to provide quality guidance and methods.
• Supports the Supplier Quality Management (SQM) system.
• Supports Internal Quality Audit (IQA) program through completion of internal audits according to audit schedule.
• Assists validation by reviewing protocols, execution of protocols, reviewing / writing of final reports.
• Provides monthly quality indicators and improves results.
• Applies the requirements fixed in the Quality Assurance and ensure that the procedures are followed.
• Participates in customer audits.
• Ensures that the ISO, cGMP, USDA guidelines and corporate policies are followed.

Who You are:

Minimum Qualifications

• Bachelor's degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology, etc), or a quality discipline (e.g., Quality Assurance, Regulatory Affairs, etc.).
• 3+ years' experience in a Quality environment.

Preferred Qualifications

• 5+ years progressive responsibility and experience in a drug manufacturing, medical device, or biologics industry in Quality Assurance position.
• Project management experience.
• Experience in development and management of CAPA, Change Control, and document control systems and internal/ external audit processes.
• Expertise in cGMPs, FDA regulations, and SOP development.
• Basic computer skills and a working knowledge of basic (Microsoft Office (Word, Excel, PowerPoint, etc.) and MiniTab.
• Six Sigma training/certification.
• Strong verbal and written communication skills including the ability to conduct verbal presentations.
• Certified Quality Auditor (CQA).

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

This job has expired.