USA - LIMS Project Leader III (IT) (contract)

Responsibilities

• Ensure site on-time implementation of OneLIMS Raw Materials activities through support of master data requirements definition, functional design, master data configuration and data migration, site system validation, SOP revisions, and development of end-user training
• Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability, and R&D operations
• Support business and Global IS LIMS Administrator in the creation, validation, and maintenance of reports, calculations, and queries
• Manage the master data management process, including updating specifications and analysis, and supporting the approval and verification process
• Manage Global System updates and changes, which may include new modules and workflow changes
• Configure and maintain instrument interfaces to laboratory equipment
• Support the business and IS LIMS Administrator in the definition, approval, and validation of new business requirements
• 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
• Support the creation of new master data for new LabWare System build for Raw Materials into ONE LIMS Global System
• Translate data from existing electronic systems for use in mass upload tools and configuration

Qualifications

• Working knowledge of aseptic processes, biology, chemistry, and life sciences
• Strong supervisory and leadership skills
• Knowledge of cGMPs and regulatory requirements
• Strong analytical and balanced decision-making skills
• Excellent written and verbal communication skills
• Ability to lead and participate in cross-functional teams
• Familiarity with 21CFR Part 11 data integrity best practices in a pharmaceutical environment
• Experience with SQL and database structures (preferred)
• Strong project management skills (preferred)
• Experience 3+ years of experience in the use and administration of a LabWare LIMS, including LIMS Basic
• Strong working knowledge of laboratory processes, including cGMPs in a pharmaceutical environment
• Experience in system testing, validation, and master data management
• Experience or familiarity with the laboratory environment
• Experience with other systems such as laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, Lab X, or SAP (preferred)
• Experience migrating master data from LabWare V6 to LabWare V8 (preferred)