System Analyst

• Develops and maintains basic computer-based information systems or portions of systems for assigned systems or business units.
• Performs research and fact-finding to develop or maintain computer-based informa­tion systems.
• Prepares detailed specifications from which programs will be written.
• Performs basic system analysis and design following supported guidelines and procedures.
• Designs, codes, upgrades, tests and debugs information systems.
• Provides expertise in the implementation and integration of purchased software as appropriate.
• Maintains and docu­ments informa­tion systems.
• Assists with coordination and installation of application programs.
• Provides support and training to system users, including “on-call” support as required.
• Maintains and enhances current professional and technical knowledge, contributes to team effort, and secures client confidence to provide quality service.
• Bachelor's in Business Administration, Finance or Management Information; or an equivalent combination of education and or experience in a related field.
• Must have a background which would not preclude a security clearance granted.
• Our client's business unit is purchasing the use of the Logbook module from Instep. This is an electronic software program that will reside in the Cloud.
• Existing paper forms will be recreated using this software module along with newly created forms.
• The forms in some instances will be linked to other forms to allow for faster form completion in use on study or facility work.
• The process needs to be captured into a Standard Operating Procedure.
• The Logbook module will need to be validated along with the forms needing to be qualified.
• Validation testing must be written towards client's computer system validation procedures.
• Objective. The objective is to create forms to collect data in a validated software module that is compliant with the GLP regulation 21 CFR Part 11.

• Task/Deliverable.
• Create up to 50 forms within the Logbook Module.
• Link appropriate forms to each other.
• Task/Deliverable.
• Write a Validation Procedure, validate Logbook, and write the validation report.
• Task/Deliverable.
• Write a Standard Operating Procedure on the creation of forms within Logbook.
• Task/Deliverable.
• Train up to ten (10) staff members on how to create forms and validate them in the Logbook Module.

• Logbook Validation Procedure.
• This validation document will outline the definition of task, what is the intended use of the system, the implementation status and configuration requirements.
• Logbook Validation Report.
• This report will contain a summary of the results of testing, identify any outstanding issues and corrective actions, and identify procedures and training for the system. It also represents, once approved, that the system is ready for use.
• Logbook Standard Operating Procedure (SOP).
• The system SOP will state the purpose and define processes that ensure the quality and integrity of the data generated using the solution.
• It must be written in sufficient detail to clearly describe the operation of the system to be performed.
• Weekly Status Update Meetings with Meeting Minutes.
• This meeting should provide a status detailing the progress made during the previous week and a plan for the following week.
• Deliverable Schedule and Status.
• All deliverables shall be provided only to the Technical Point of Contact.
• Deliverables SubK SOW Reference Due Date/Delivery Date(calendar days).
• Create up to 50 Forms 3.1 90 days after task award.
• Validation Procedure and Validation Report 3.2 90 days after task award.
• Standard Operating Procedure 3.3 90 days after task award.
• Meeting Minutes 4.4 The day following the weekly meeting.

Salary : $28 - $32