Validation Analyst

Company Name: Staffit-Now, Inc
Location: San Diego, California-92101
Max Rate: 45 $/hr
Status: Contract
To Apply Go To www.staffitnow.com and Enter job Id 656392

Description: (Visit the site for detailed description)
Short Description:
Providing controlled software builds and releases
Troubleshooting Build-Related Issues
Ensuring CM Control over all released software
Managing and enhancing the CM process documentation base
Ensure compliance with FDA defined CM process Complete Description:
8 10 years in a combination of configuration management and software development experience required in a regulated software engineering environment. Experience with integration of internally and externally developed software is required. Specific experience with PVCS Tracker, Perforce, and DOORS is preferred; as well as a wide breadth of experience and environments with commercially available configuration management software, defect tracking systems and requirements management tools

E. PROBLEM SOLVING:
Responsible for resolving and troubleshooting build-related issues on a daily basis. Act to ensure that all software developed internally and externally is under configuration management controls, and has a defined and documented CM process. Ensure traceability between software configuration items, requirements, and defect tracking systems. Review and audit software changes, plans and processes to ensure compliance to the FDA s requirements with respect to Software Configuration Management functions. Work with Quality and other teams to manage site-level CM operational procedures. Timely development of CM-related documentation, and provision of all the necessary project-related documentation to support project schedules


F. ACCOUNTABILITY:
The position must ensure the integrity of software developed and released through the San Diego Software Engineering Center of Excellence, and will work closely with both the Software Verification and Software Development functions.

G. ANALYTICAL ABILITY
It is essential that CM be proactive in analysis of source control and defect tracking data, in order to maintain proper traceability between the two data sets, and driving requirements.



H. AUTHORITY TO ACT:
CM is expected to act independently under normal, day-to-day circumstances, reporting to management on a weekly basis. CM should know when to elevate issues that impact multiple teams to management levels and provide input as to how these issues are to be addressed, and act in a timely manner to requests from management.

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