USA-Process & Master Data Governance Manager I (Professional)

TalentBurst; Swiftwater (Monroe County); On-site; USD 60,000 - 80,000; Full time

Job summary

Une entreprise de positionnement dans le secteur pharmaceutique recherche un Manager en Process & Master Data Governance pour aider à la maintenance du système LIMS. Ce rôle implique la mise à jour des données et la conformité avec les normes. Le candidat idéal doit posséder une solide connaissance des processus de laboratoire et au moins un an d'expérience en administration LIMS.

Qualifications

• 1+ ans d'expérience en administration LabWare LIMS.
• Connaissance des processus de laboratoire, cGMP.
• Compétences en documentation GMP souhaitables.

Responsibilities

• Supporter l'implémentation du système iSHIFT (ERP) pour la gestion des données maîtresses.
• Fournir un support technique LIMS aux opérations de contrôle qualité.
• Gérer le processus de gestion des données maîtresses.

Skills

Analytical skills

Decision-making

GMP Documentation

Communication skills

Education

HS Diploma

Job description

Process & Master Data Governance Manager I
Swiftwater PA
6 Months (Possible extension)

Position Summary:
The Lab Information Management System [LIMS] Business Administrator is essential to Quality Operations at the 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 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 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

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