Labware LIMS Analyst Job in Cranbury, New Jersey US
Provide Software Development expertise for LabWare LIMS System for the Research community and potentially other systems at Purdue Pharmaceuticals. Primary responsibility is the design, development, validation and life cycle management of production LabWare LIMS software. This role formulates and recommends system scopes and objectives along with various strategic uses of LabWare LIMS in order to meet business goals. This role will focus on primarily on software code development, system configuration and validation deliverables with attention to procedures for solving Laboratory problems utilizing IT best practices. This role will coordinate efforts with the LIMS support team to meet defined targets. This role will prepare detailed specifications from which programs will be written, designed, coded, tested/validated and debugged in line with LIMS team project schedule. This role will provide and develop all necessary change control/regulatory documentation required to demonstrate appropriate system compliance. The LabWare LIMS Analyst - Research role serves as the primary development resource for the LIMS support team providing an in depth working knowledge of the LabWare LIMS software and the customization of that software. This role will also serve as the primary development liaison with Research customers at the Cranbury, NJ facility for trouble-shooting, analysis and development/implementation of system enhancements.
PRINCIPAL ACCOUNTABILITIES:
1. Serve as a LIMS Development/project resource for Purdue Research facility.
2. Set priorities for problem resolution.
3. Develops relationships with vendors and 3rd party consultants
4. Maintain data integrity of the system and ensure validated state.
5. Insure proper maintenance of the system hardware, software and network infrastructure
6. Maintain the system configuration and security, document such configurations
7. Monitor and enhance system performance
8. Communicate pertinent system information to LIMS team as needed.
9. Create, validate and implement improvements to the system, based on site needs
10. Identify, document and communicate new site business requirements.
11. Work with the Research customers in conjunction with the LIMS team to identify and develop enhancements and new functionality.
12. Coordinate implementation of new functionality or upgrades in Cranbury, and other sites as required.
13. Maintain open communication with the LIMS team and Research customers to maximize resource usage.
14. Support laboratory management in re-engineering initiatives
15. Maintain system related SOPs
16. Develop tools for LIMS decision support to be used by the site
17. Develop and maintain documentation required for regulatory compliance. Ensure documents are properly stored, both hard copy and soft copy in document management system.
18. Interface with regulatory agencies during inspections/audits
19. Other duties as assigned and as required.
Educational Requirements
Bachelor's degree in Computer Information Systems, Computer Science, Computer programming, or related technical field and a minimum of 6 years of relevant experience supporting laboratory systems.
Required Experience Technical Requirements
Qualifications/Competencies:
General Skills:
- Computer literacy, including familiarity with MS Office applications
- Well-developed writing skills
- Initiative, self-direction and ability to adapt to changing priorities
- Ability to investigate and resolve problems within a structured process
- Knowledge of GMP requirements in the pharmaceutical industry
- Experience with computer code/programming and troubleshooting
- Knowledge of pharmaceutical processes (Prefer minimum of two years of experience in a pharmaceutical environment)
Specific Skills:
- Knowledge of Computer System validation requirements.
- Ability to create validation documents, using established formats
- Ability to read, modify and write computer code is desired
- Ability to design, execute and document solutions to system problems
- Ability to create validation documents, using established formats
- Presentation skills for group presentations, training
Education / Experience:
- 3-5 years experience with LabWare LIMS is preferred.
- Working knowledge of the Velquest software package is preferred.
- Knowledge of pharmaceutical processes (Prefer minimum of two years of experience in a pharmaceutical environment)
- Experience with computer programming code (e.g. C++, Visual Basic) preferred
- Experience with SQL Plus, PL SQL or other 4GL query language preferred.
