GxP Laboratory Systems Administrator

Responsibilities

• BusinessSupport and system administration for identified applications
• Perform investigation and resolution efforts for technical and business process issues
• Communicate technical issues and resolutions with users and department managers
• Troubleshoot and collaborate with end users and departmental managers
• Maintain a high level of functional subject matter knowledge for the assigned applications
• Escalate issues to application vendors as necessary
• Perform other duties as assigned

Requirements

• Bachelor’s degree in computer science or life sciences, other related field, or equivalent experience
• 4+ years experience related to the administration, operation, and maintenance of Laboratory Information Management Systems (LIMS)
• Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment
• Advanced knowledge of computer programs (e.g., MS Word, MS Excel, computerized data acquisition systems)
• Ability to multi-task and participate in multiple projects and department initiatives concurrently
• Ability to produce high quality results while working under the pressure of strict deadlines
• Function effectively independently, as necessary, and work with others to achieve team goals

Qualifications

• Extensive experience validating and supporting Agilent laboratory systems (Openlab, Chemstation, Cary UV systems)
• Excellent experience with pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV/CSA validation, 21 CFR Part 11, EU Annex 11, SDLC)
• Experience with regulated environment asset management applications and environment monitor applications
• Computer System Validation, 21 CFR Part 11, Annex 11, and GxP
• Prior Pharmaceutical or CRO experience
• Project Management certification