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System Administrator IV
Ref No.: 18-01300
Location: Swiftwater, Pennsylvania
Position Type:Contract
Start Date / End Date: 05/21/2018 to 12/31/2018
Duties
The 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 and IS LIMS Administrators in report design and build, 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.
KEY ACCOUNTABILITIES
- Ensure site on-time implementation of LIMS through support of requirements definition, functional design, master data configuration and data migration, system validation, SOP revisions and development and end-user training. Provide technical support of LIMS to Quality Control operation
- Support business and IS LIMS Administrator in the creation, validation and maintenance of reports, calculations, queries
- Provide first level diagnostic of incidents and support business users, IS LIMS Administrator andSupportCenterin the management and timely resolution of technical incidents through the standard incident and problem management process
- Responsible for the master data management process including the updating of specifications and supporting the approval process
- Support the business and IS LIMS Administrator in the definition, approval and validation of new business requirements
- Play a key role in system governance through participation in local, regional and global governance committees
- Provide ad hoc support to other departments to ensure compliance with all regulatory standards
- Support audits and inspections to provide data and information on request
- Create and maintain processes to improve the regulatory review process
- Ensure that the LIMS complies with all relevant regulatory standards Develop and manage LIMS improvement projects
- Establish and lead required change controls
- Improve process efficiency Support the training of new users
- Support the business in the creation and updating of training materials as changes to system occur
- Support the business in the delivery of training to end users and support management of associated system training records
- Provide local advice and support to users
- Write and revise processes and documentation
- Support the process documentation process

Required Experience
- 3-5 years of experience in use and administration of LabWare LIMS
- 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 ERES requirements
- Excellent written and verbal communications skills and the ability to lead and participate in teams
- Experience or familiarity of the Laboratory Environment
Preferred Experience
- Familiarity with other systems (E.g. Laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, TrackWise, SAP)
- Experience in development and delivery of end user training
- Ability to assess processes and workflows to determine opportunities for improvement
- Strong Project Management Skills

Bachelor Degree in Computer Science, Life Sciences (Biology, Chemistry, or related discipline) preferred