Data Integrity Specialist - Hybrid

Posté 24 janv. 2023

Rockville, Maryland - United States

Demander un identifiant 259539

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.

Your Role:

At MilliporeSigma, as the Data Integrity Specialist, you will work within the Quality department ensuring Data Integrity issues from audits are closed. In addition, you will work with cross-functional teams to ensure that the site is fully regulatory compliant with data integrity.

  • Strengthen a data integrity culture across sites, including assisting and champion the Data Integrity policies and practices
  • Take a leading role in identifying and investigating Data Integrity issues along with site operational, IT/OT and quality teams, ensuring appropriate escalation
  • Stay current on industry and global regulatory requirements for Data Integrity and act as a SME to support the organization primarily in the United States.
  • Identify and escalate systemic issues and risks in the areas of Data Integrity to your and advise on actions to remediate risks ensuring site compliance
  • Ensure the implementation of effective business process, procedures, and practices in alignment with regulatory expectations and company policies for Data Integrity through its lifecycle
  • Support audits and inspections as needed on Data Integrity related topics, working with the site quality groups, and deliver appropriate responses to data integrity and e-Compliance related observations
  • Up to 10% travel domestic and international
  • Hybrid work model

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in any discipline    -OR -
  • Associate’s Degree OR High School diploma/ GED with 5+ years’ experience in Quality & Compliance within a GxP environment.
  • 3+ years' experience in Quality & Compliance within a GxP environment

Preferred Qualifications:

  • Data Integrity experience in GxP envioronment
  • Excellent oral and written communication and interpersonal skills
  • Take initiative as a flexible self-starter, working with some direction
  • Prioritize and complete tasks on a regular schedule and meet deliverables
  • Excel in a team environment along with the ability to work independently, efficiently, and effectively
  • Participate in risk assessments and quality investigations
  • Ensure compliance to and advice the site teams on regulatory requirements, industry trends related to data integrity
  • Experience with CSV
  • Knowledge of ALCOA, Part 11, EU annex 11/GAMP
  • Proficient in Microsoft Office including Word, Excel, and Outlook
  • Execute data integrity compliance / gap assessments



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!

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