Process And Master Data Governance Manager

Job Description:

Pay Range: $68.42hr - $71.42hr

Responsibilities:

• Ensure site on-time implementation of new iSHIFT system (ERP) activities through support of master data configuration and data migration and SOP revisions.
• Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations.
• Provide first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical.
• Responsible for the master data management process including the updating of specifications and supporting the approval process.
• Manage Global System update and changes which may include new modules and workflow changes.
• Configure and Maintain instrument interfaces to Laboratory equipment.
• 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.
• Ensure that the LIMS complies with all relevant regulatory standards.

Technical Competencies and Soft Skills:

• Working knowledge of aseptic processes, biology, chemistry, life sciences
• Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills
• Good GMP documentation

Minimum Education:

• HS Diploma.

Basic Requirements:

• Must have 1+ years of experience in use and administration of LabWare LIMS, specifically creation of product specs, sample plans and item codes.
• Strong working knowledge of laboratory processes including cGMP's in a pharmaceutical environment.
• Experience in system testing, validation, and master data management
• Familiar with 21 CFR 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.