Application Administrator

Southern Research Institute•Birmingham, AL

56d•Remote

About The Position

Southern Research (SR) is at an exciting turning point in its 84-year history. With a renewed strategic focus on translational research in the life sciences, SR is committing more than $150 million toward building innovative platforms, programs, and facilities. We aim to activate the full potential of Alabama's biotech ecosystem-driving economic growth, generating new high-performance ventures, and creating high-quality jobs throughout the Southeast. As part of this momentum, the Application Administrator will report to the Director of GxP Systems and play a key role in defining and enforcing the organization's application management strategy. With deep expertise in modern technologies and a tactical mindset, the Application Administrator plays a pivotal role in enabling the digital transformation of the organization. The Application Administrator position is responsible for supporting the implementation and maintenance of various validated enterprise and laboratory systems used at Southern Research. This role is specifically focused on supporting Southern Research's Veeva Quality Vault and a subset of smaller GxP applications/systems used across multiple departments such as Quality, Toxicology, Bioanalytical, Facilities. The Application Administrator functions as the business point-of-contact for a given software application or system and is responsible for supporting the overall validated state. They shall aid in deploying solutions to production and subsequent support those solutions during the Operational phase of the lifecycle. The position works closely with the business, Validation Analysts, Information Systems, and internal Quality teams at Southern Research. The Application Administrator will serve as an expert resource, bringing forth opportunities and other complementary solutions to help support the growth of Southern Research and influence decisions regarding business process changes.

Requirements

Bachelor's degree in computer science or life sciences, other related field, or equivalent experience.
4+ years' experience in a Laboratory, Quality, or technical role (e.g., IT) with direct experience related to the administration, operation, and maintenance of Veeva Quality and/or other computerized systems used in a GxP laboratory/environment.
Advanced knowledge of computer programs used in an Office environment (e.g., MS Word, MS Excel, etc.)
Ability to multi-task and participate in multiple projects and department initiatives concurrently.
Ability to produce high quality results while working under the pressure of strict deadline.
Ability to function effectively independently, as necessary, and work with others to achieve team goals.

Nice To Haves

Extensive experience validating and supporting Veeva Quality within a GxP environment.
Exposure to Laboratory systems such as SoftMax Pro, MSD Discovery Workbench, QuantStudio, and Analyst.
Specific experience in a Pharmaceutical or CRO experience.
Specific experience with pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV, 21 CFR Part 11 and EU Annex 11).
Experience with regulated environment asset management applications and environment monitor applications.

Responsibilities

User Access Management: Provision user accounts, assign roles and manage permissions.
System Configuration: Setup and maintain application settings such as security, metadata, and workflows.
Compliance and Validation: Support validation activities, including but not limited to, testing, SOP authorship, and User Training.
Change Management: Facilitate and drive change management activities (including configuration), as necessary.
Application Support: Perform investigation and resolution efforts for technical and business process issues. Communicate issues and resolutions to users, department managers, and other stakeholders. Escalate issues to management, communication, and work with application/system vendors as necessary.
Point of Contact: Function as the business and vendor point-of-contact for the system.
System Documentation: Maintain the system binder, ensure the documentation generated for the system is compiled and accessible.
Periodic Review: Ensure compliance and overall validated state is maintained during the Operational phase. Document through Periodic Review and other user maintenance activities.
Identification of data integrity and continuous improvement opportunities.
Troubleshoot and collaborate with end users and departmental managers.
Maintain a high-level of functional subject matter knowledge for the assigned applications.
For Enterprise level systems, a member of system governance boards and working groups, contributing in KPI reviews.
Perform other duties as assigned.
Contribute and support computer system validation projects, including application change control as required by GxP, Southern Research policies and procedures.
Draft CSV documentation as needed: configuration specifications, functional and user requirements specifications, test scripts, deviations, etc…
Perform periodic application review and management of user access.
Ensure all application and system documents meets GxP compliance requirements and are audit-ready.
Represent the application documentation in client and regulatory audits.
Contribute to audit finding responses.
Establish open communication between the Business, Information Systems and Quality.
Triage escalation of technical issues to Information Systems and Management.
Create and perform updates to application specific documentation (e.g., System Log, User Lists, etc…).
Coordinate release of new versions of applications into respective environments including Development, Validation, and Production environments.
Develop business scenarios to test applications.
Verify installation and operation of applications.
Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes).
Lead or support process improvement initiatives as necessary.
Administration and/or application of Windows technical controls as appropriate.