Job Title:

Process and Master Data Governance Manager 1

Duration:

3+

Months Location:

Swiftwater, PA

Description

The Lab Information Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and improvement of the LIMS system.

Maintenance support will include supporting the Business by updating master data for new and existing products, updating master data for new and existing analysis, maintaining system documentation, and providing ad hoc support to other departments.

Support the creation of updating master data (Product, Item code and Sampling plan) in support of data remediations and SPC projects.

Position Responsibilities:

• Ensure site on-time implementation of data remediation activities through support of master data configuration and data migration and SOP revisions
• Responsible for the master data management process including the updating of specifications, and analysis and supporting the approval and verification process
• Ensure that the LIMS complies with all relevant regulatory standards
• Support the business in the creation and updating of training materials as changes to system occur
  Technical competencies and soft skills:
  Working knowledge of aseptic processes, biology, chemistry, life sciences with strong supervisory skills
  Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills
  

Basic Requirements:

1-3 years of experience in use and administration of a LabWare LIMS including LIMS Basic

• Strong working knowledge of laboratory processes including cGMP s in a pharmaceutical environment
• Experience in system validation, and master data management
• Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment
• Excellent written and verbal communications skills and the ability to lead and participate in teams
• Experience or familiarity of the Laboratory Environment
  Preferred Requirements
• Experience with SQL and database structures
  Job Posting Number of Positions
  1
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