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:

• Bachelor Degree in Information Systems, science or related field
• Minimum of three to five years of working in a cGMP regulated environment
• Experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) are strongly desired. (Biovia/Qumas and SumTotal a plus)
• Quality Control experience is desired.
• Knowledge of FDA and EMA regulations and compliance concepts (e.g. 21 CFR Parts 11, 210, 211, 820).

SUPERVISORY RESPONSIBILITIES: None

QUALIFICATIONS:

• Excellent oral and written communication skills.
• Good interpersonal skills to be an effective trainer and mentor for users of the quality systems.
• Presents a solid understanding of quality assurance concepts and practices.
• Exercises independent judgment to optimize some commonplace compliance procedures.
• Displays an emerging ability to manage client expectations.
• Displays an emerging ability to develop innovative ideas for solving problems.

COMPUTER SKILLS:

• Must be proficient in MS Office Suite.

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.

• Requires physical activity such as standing for long periods of time, walking, bending, and working with hands.

WORK ENVIRONMENT:

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

• No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions