Category: Scientific & Clinical
Title: LIMS Specialist II (Experienced)
Location: West Point, PA
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- The Laboratory Information Systems (LIMS) Specialist is responsible for supporting site business in updating master data for new and existing products, updating master data for new and existing analysis and maintaining system documentation.
- Processes change controls for the LIMS system following applicable procedures and documents changes in an electronic repository.
- The projects assigned are technical in nature and require a working knowledge of analytical testing methods and GMP Compliance.
- Ensure on time implementation of LIMS static data changes through collaboration with business areas in support of requirements definition, functional design and master data configuration.
- Provide technical support for LIMS to site.
- Act as first level diagnostic of incidents and support end users and Support Center in the management and timely resolution of technical incidents through the standard incident and problem management process.
- Provides 100% second person review support for team members change control documents to source documents to ensure accuracy, compliance, integrity, completeness.
- Support the business in the creation and updating of training materials as changes to system occur.
- Incumbent must complete technical assignments independently once specific objectives have been defined.
- Bachelor’s Degree or higher in Chemistry, Biological or Computer Science
- 2+ yrs of LIMS hands on experience in the pharmaceutical environment.
- Use of LabWare v6 including but not limited to knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, reagent and instrument managers, reports and query tools is preferred.
- Candidate must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
- Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
- Programming experience (E.g. SQL, LIMS Basic)
- Experience using Microsoft Access, Word and Excel
- Familiarity with other systems (E.g. TrackWise, SAP, Crystal Reports, MIDAS)
- Ability to write UAT scripts and support execution of UAT
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.