Master Batch Record (MBR) Designer Job at GMP Pros, Inc., Omaha, NE

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  • GMP Pros, Inc.
  • Omaha, NE

Job Description

Job Description

Job Description

Salary:

Intrepid: Master Batch Record (MBR) Designer

We are proud to be a Great Place To Work US - Certified company!

Check out what our employees say makes working here so great:

Position: Master Batch Record (MBR) Designer 1099/Remote (10% travel required)

We are looking for candidates fluent in English and one or more of the following languages: Italian, French, or Portuguese.

This role requires effective written and verbal communication skills to support global operations.

What You Can Expect:

  • Hard work, relentless challenges, and the pressure of high expectations.
  • Generous recognition in times of success, yet unwavering support during setbacks.
  • A journey that will test your limits and push you to new heights.
  • The opportunity to make a significant impact and leave a legacy.
  • The camaraderie of a dedicated and passionate team.

Key Responsibilities:

  • Author GMBRs (approx. 5,500) to support client with Global deployment of MES
  • Author and create GMBRs according to client design standards and best practices
  • Support creation and input of Master Data
  • Report to Center of Excellence project team and take direction from program-level management
  • Collaborate with individual site teams according to local deployment strategies
  • Attend and support regular cadence of site-level meetings, to include project review(s), periodic standup(s), periodic status review(s), design review(s), and working sessions.
  • Give informed input on design strategy based on industry best practice
  • Adhere to all design and project timelines
  • Actively communicate design and project risks and escalate to relevant GMP Pros stakeholders
  • Support GMP Pros governance through cascading information and project status updates

Qualifications:

  • 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.
  • Proven ability to operate under high-pressure in a timeline constrained environment.
  • Ability to travel internationally

** Apply now and be part of something extraordinary.**

Pre-Employment Requirements :

  • Pass and maintain pre- employment/contract background check and safety certification, including outstanding professional references.
  • Subject to motor vehicle report review.
  • Maintain valid drivers license and endorsements as required per position.
  • Pass pre- employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
  • Successfully complete and maintain any required safety certification and testing annually.
  • Candidates for positions that include remote, or hybrid opportunities must provide their own access to a secure high-speed internet signal (preferably hard wired) at a capacity sufficient to support video, web, and email processing simultaneously based on their personal work environment. This is typically 100Mb and above

Key Words: PAS-X, GMBR Designer, MBR Designer, eBR, MES

GMP Pros is an Equal Employment Opportunity / Affirmative Employer (EEO/AA) and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status are strongly encouraged to apply.It is the policy ofGMP Prosto provide equal opportunity in employment for all qualified individuals regardless of race, color, religion, ethnicity, national origin, ancestry, disability, medical condition, age, citizenship, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, genetic information, military status, veteran status, and any other characteristic protected by law.

By submitting material for consideration for this position you are attesting that no material or interaction with GMP Pros Team Members establishes any obligation for GMP Pros to hire you. If you are hired, you understand that either GMP Pros or you can terminate your employment at any time and for any reason, with or without cause and without prior notice. Further, you understand that no representative of GMP Pros has the authority to make any assurance to the contrary.

By submitting your application for this position, you attest that you have given GMP Pros true and complete information on this application. No requested information has been concealed. You are authorizing GMP Pros to contact references provided for employment reference checks. If any information youhave provided is untrue, or if you have concealed material information, you understand this will constitute cause for the denial of employment or immediate dismissal.

Accessibility: If you need help accessing this page, please contact: Phone: 402-225-6565 Email: HR@gmppros.com If you want to view the EEO is the Law poster, please choose your language: English Spanish Arabic - Chinese

This company participates in the United States Department of Homeland Security E-Verify program. The E-Verify program is an internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services. Please use the links provided for important information when applying for work with this company: Everify English / Spanish

remote work

Job Tags

Contract work, Local area, Immediate start, Remote job,

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