Summary: Coordinates and prioritizes electronic laboratory data systems projects (Empower, DataPro, Softmax, StatLIA, Chromperfect etc.) to maintain harmonization across IOPS sites and compliance with regulatory guidelines.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Works with cross functional teams to conduct data integrity and permission assessments
- Work with cross-functional teams to define and prioritize electronic laboratory data systems projects and initiatives.
- Ensure harmonization of electronic laboratory data systems use and management between laboratory environments.
- Contribute to the global harmonization projects of laboratory data systems.
- Review updates to regulatory guidelines for electronic data systems and ensure continuing compliance.
- Coordinate the needs of QC functional areas and establish priorities for electronic data systems configurations, such as implementation of new specifications, design of system templates for new/revised test methods, design of queries and reports.
- Bring up issues, such as priority conflicts or project timeline delays, to QC management.
- Work with the IT LIMS and Lab System groups on projects such as defining User Requirement Specifications, execution of test plans.
- Provide support for additional computerized systems such as: LIMS (Laboratory Information Management System)
- Provide training and support to QC end-users.
- Write and revise Standard Operating Procedures (SOPs), User Requirement Specifications (URSs) and Functional Requirement Specifications (FRSs) with current formats.
- Review documents and ensure consistency with SOPs and current formats
Education and Experience:
- BS/BA in Life Sciences or related field and 3+ years of experience or equivalent combination of education and experience.