Job Description

Title: Process & Master Data Governance Manager I

Location: Swiftwater, PA

Duration: 8+ months

Shift hours: 8-4:30 EST M-F

NOTE:

• Minimum Education: HS Diploma Open to candidates willing to relocate at their own expense
• Fully onsite.
• Free parking onsite

Must have experience:

• 1+ years of experience in use and administration of a 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 (LIMS).
• Familiar with 21CFR part 11 data integrity.
• Best practices in pharmaceutical environment (previous FDA experience).
• Experience or familiarity of the Laboratory Environment (highlighted lab exp).
• Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations (responding to tickets, helping users).
• Preferred/ Nice Have Skills: -Additional LIMS experience, building master data.

Job 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 Business Administrators in, 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.
• The position is expected to provide leadership to support system evolution and continuous improvement, and to support laboratory informatics needs.
• This role will support the creation and updating of master data to support the site transition to toa new ERP.
• Translation of data from existing documents to the electronic system for use in production and QC.

Position 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 first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical issues.
• Responsible for the master data management process including the updating of specifications and supporting the approval process.
• Manage Global System updates 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 the 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.

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