Technical Support Specialist Quality Systems

The Technical Support Specialist is responsible for the administration of electronic systems that support Quality System operations. These systems include but are not limited to the Document Management System, Learning Management System, and Laboratory Systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned :

• Provides day-to-day support including business administration and management of user accounts.
• Provides guidance and trains users in quality systems software applications
• Resolves issues and provides basic problem resolution related to electronic systems that support Quality Systems or escalates to IT or 3rd party support.
• Support the QA GMP Validation group for the assessment of Computerized Systems Validation including 21-CFR-Part 11 assessments.
• Develop processes / procedures as needed to support electronic systems that support Quality Systems.
• Partners with IT Applications and IT Validation and Compliance functions regarding the installation of all system updates, upgrades, integrated tools, and other software integrations
• Support QA GMP Validation group and other validation initiatives as needed for Quality / Enterprise Systems.
• Participates in Software Development Lifecycle (SDLC) activities from user / functional requirements, design, configuration, change controls, and testing.

EDUCATION AND / OR EXPERIENCE :

SUPERVISORY RESPONSIBILITIES : None

QUALIFICATIONS :

COMPUTER SKILLS :

CERTIFICATES, LICENSES, REGISTRATIONS : None required.

PHYSICAL DEMANDS :

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

WORK ENVIRONMENT :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

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