Design Master Batch Record Specialist

4 days ago


Omaha, Nebraska, United States GMP Pros, Inc. Full time
Job Overview

We are seeking a highly skilled Design Master Batch Record Specialist to join our team at GMP Pros, Inc.

About the Role

This is a unique opportunity to work on high-profile projects and make a significant impact on our company's success. As a Design Master Batch Record Specialist, you will be responsible for designing and creating Master Batch Records (MBRs) to support client deployment of Manufacturing Execution Systems (MES).

You will work closely with our project teams and stakeholders to ensure timely delivery of high-quality MBRs that meet client design standards and best practices.

Key Responsibilities
  • Design and create approximately 5,500 Master Batch Records (MBRs) in accordance with client design standards and best practices
  • Support the creation and input of Master Data
  • Collaborate with individual site teams according to local deployment strategies
  • Attend regular meetings, including project reviews, standups, status reviews, design reviews, and working sessions
  • Giving informed input on design strategy based on industry best practices
About You

To be successful in this role, you will need to have:

  • Proven experience (5+ years) in FDA regulated manufacturing with electronic batch record design in Werum PAS-X (3.1.8 or 3.3)
  • Proven knowledge of FDA and CFR requirements pertaining to batch record design and documentation
  • Exceptional interpersonal skills and the ability to collaborate across project teams and workstreams
  • Strong problem-solving capabilities and a proactive approach to overcoming obstacles
What We Offer

We offer a competitive salary and benefits package, including remote work options. The estimated annual salary for this position is $90,000 - $120,000 depending on experience.

The company participates in the United States Department of Homeland Security E-Verify program. We value diversity and equal employment opportunities and encourage all qualified applicants to apply.



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