LIMS Business Administrator Sr-Swiftwater, PA

Job description

Position Summary:
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 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.
 
Position Responsibilities:
- Ensure site on-time implementation of LIMS activities through support of requirements definition, functional design, master data configuration and data migration, 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, queries

- 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

- 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

Technical competencies and soft skills:
Working knowledge of biology, chemistry, life sciences with strong supervisory skills
Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision making skills
Strength in several LEAD Competencies-Think Strategically, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
  
Soft Skills:
Communication
Writing
People Skills
Analytical
Negotiation
Organization
Detail Oriented 

Basic Requirements:
BS in Bachelor Degree in Computer Science, Life Sciences (Biology, Chemistry, or related discipline)

- 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 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

Preferred Requirements

- Experience with other systems (E.g. Laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, TrackWise, SAP)

- Experience with SQL and database structures

- Experience in development and delivery of end user training

- Ability to assess processes and workflows to determine opportunities for improvement

- Strong Project Management Skills

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.