Description

Application Administrator

Application Administrator (Remote) Southern Research + You
Discover a career where your work truly matters. Southern Research has been translating science into real-world solutions since 1941. Join our innovative team and enjoy benefits like medical, dental, vision, 401(k) match, life insurance, PTO, an employee assistance program, and more. General Summary 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. Position Specifics 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. Essential Duties & 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.

Regulatory

• 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.

Information Systems

• 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.

Requirements/Minimum Qualifications

• Education & Experience
  • 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.

Preferred Qualifications

• 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.

Core Values Cultivating human connection putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust. Operating with precise execution measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing. Harnessing relentless curiosity our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results. Stewarding a healthy community implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked. Job Specific Behaviors Relationship Orientation Develops positive relationships by making others feel their concerns and contributions are important. Continuous Learning Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning. Tolerance for Stress, Ambiguity & Change Demonstrates flexibility in applying different approaches to changing work demands. Effective Communication Creates a team environment in which information flows freely and decision making is based on a win-win philosophy Compliance Applies an understanding of key legal precedents, policies and practices to protect the interests of the organization. Cross-team Collaboration Ensures integration and cooperation across organizational boundaries Attention to detail Utilizes established monitoring system, records data accurately and in a timely manner, and ensures accuracy of data. Planning and Organization Systematically identifies issues to be addressed and helps plan a course of action for self and others to ensure the accomplishment of specific objectives Operational / Technical Excellence Ensures that work product (whether service or process) enables the organization to deliver on customer's expectations. Physical Demands

• Ability to perform work utilizing a computer for extended periods of time.
• Ability to sit for extended periods of time without being able to leave the work area.
• Ability to stand for extended periods of time without being able to leave the work area.

Work Authorization
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

PI280504522