Title: LIMS Business Administrator/ Process & Master Data Governance Manager I
Location: Swiftwater, PA
Duration: 3-4 Months+ Possible Extension
Pay Range: $60-$70/hr
Manager Notes:
Approximately 1 3 years of hands-on LabWare LIMS experience.
Direct experience working with: Product specifications Sample plans / Sampling plans Item codes LIMS master data candidate should be comfortable working within LabWare LIMS and performing routine master data activities.
Strong practical experience with the specific master data components above is more important than having extensive overall LIMS experience.
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
Numbers & Facts
Location
Swiftwater, PA
Salary
$60–$70 Per Hour
Skills
Analysis Skillsunmatched
Asepsisunmatched
Best Practicesunmatched
Biological Processesunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Business Administrationunmatched
Business Processesunmatched
Business Supportunmatched
Chemistryunmatched
Code of Federal Regulationsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Migrationunmatched
Data Processingunmatched
Data Qualityunmatched
Documentationunmatched
Laboratory Information Management System (LIMS)unmatched
Labwareunmatched
Leadershipunmatched
Master Data Management (MDM)unmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Systems Maintenanceunmatched
Team Playerunmatched
Time Managementunmatched
Writing Skillsunmatched
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