Job Title Senior Analyst Job Location Frederick, MD Contract Duration 6 months with possibilities of extension Ideal Candidate Profile Ranking of Preferred Systems KnowledgeExperience 1. Empower 2. Computerized systems management (general user support, software upgrades, etc) 3. Labware LIMS Job Responsibilities Perform day-to-day activities of QC computerized systems, such as LIMS, OpenLab, Empower, and lab computer systems Perform application administration tasks for QC computerized systems Liaison between QC and the Validation group with relation to softwarecomputer system validation. Liaison between QC and IT to administrate all softwarecomputer applications and fulfill all networking and security requirements. Liaison between QC and Operations IS in maintaining LIMS, OpenLab, and other enterprise systems. Liaison between QC and outside vendors for instrumentequipment installation and maintenance. Create and manage deviations, change controls, and CAPAs related to QC computerized systems. Work with Operation IS to implement changes to corporate systems such as LIMS, OpenLab, etc. Business analysis of new technology for the site. Represent QC business for new system implementation at the site. CreateMaintain SOPs related to QC information systems. Manage QC system interface with other enterprise systems such as SAP. Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement. Required Complete understanding and wide application of technical principles, theories, and concepts in the Information Systems, biologics and GMP fields. Experience managing small projects and statistical analysis of data a plus. General knowledge of other related disciplines with IS and biologics. Preferred Education and Years of Experience Bachelors Scientific Biotech Pharmaceutical IT field of study Preferred 4 years information management experience Associated topics: assay, internship, lab, laboratory technician, laboratory technologist, lab tech, lab technologist, qa, qc, research
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