Job DescriptionResponsibilities:
•Acts as administrator for Quality computerized systems such as LIMS, Empower, and lab computerized systems including Windows permissions.
•Serves as subject matter expert for Quality computerized systems and ensure compliance to regulatory requirements such as 21 CFR Part 11 and Annex 11.
•Day-to-day management and continuous improvement of all QC computerized systems/processes.
•Plans and leads Quality IT projects, such as LIMS implementation and lab instrument qualification.
•Works with Quality, IT, and Validation to support Quality computerized system lifecycle management activities from concept, development, validation, implementation and maintenance to retirement.
•Supports a harmonized approach with team members across all network sites for Quality systems.
•Authors and reviews protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality computerized systems.
•Monitors Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.
•Assists with data integrity initiatives as they relate to Quality computerized systems.
•Leads periodic reviews of existing computerized systems and identify process improvements coordinating implementation of new processes.
•Creates/maintains SOPs and training related to Quality IT systems.
•Represent Quality IT during meetings.
Communicates and tracks all follow-up items through to completion.
•Other related duties as assigned.
Requirements:
•Bachelor’s degree in a Scientific, Biotech, Pharmaceutical or IT field of study with 6 years working in a GxP pharma or biotech environment preferred.
•3 years instrument administration experience preferred.
•3 years’ experience with LIMS administration.
STARLIMS® is required
•Familiarity with Windows permission settings, network domain, and a general understanding of server architecture.
•Prefer familiarity with SQL, Java, or other LIMS programming language.
•Experience should include lifecycle management of Quality computerized systems.