Application Administrator

Application Administrator - Provantis

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

The Application Administrator position is responsible for supporting the implementation, evolution and maintenance of validated enterprise and laboratory systems used at Southern Research. This role will specifically include support of Southern Research's Provantis LIMS and a subset of other GxP applications/systems used across multiple departments such as Quality, Toxicology, Bioanalytical, and/or Facilities.

The Application Administrator functions as the business point-of-contact for a given software application or system at Southern Research. They provide advanced knowledge and stewardship with relation to application administration, security controls, system integrations, configuration, and vendor management (where applicable). They aid in deploying new solutions to production and the subsequent support those solutions during the Operational phase of the lifecycle. They are responsible for the overall validated state of the system within a GxP Environment.

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. Help build out studies and interfaces as appropriate.
• 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, communicate and work with application/system vendors as necessary.
• Point of Contact: Function as the business and vendor point-of-contact for the system and SaaS deployments.
• System Documentation: Maintain the system binder, ensure the documentation generated for the system is compiled, accessible, and audit ready.
• Periodic Review: Ensure compliance and overall validated state is maintained during the Operational phase. Document through Periodic Review and other user maintenance activities including review of vendor documentation (e.g., SOC2).
• 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

• 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 preclinical study management software (e.g., Instem Provantis or Xybion Pristima) and 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…) and software ticketing systems.
• 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 Instem Provantis preclinical study management software.
• Experience supporting other laboratory systems (e.g., SoftMax Pro, WinNonlin, QuantStudio, or Analyst) and Enterprise systems (e.g., environmental monitoring, asset management, or LIMS).
• Specific experience in a Pharmaceutical or CRO experience and pharmaceutical/CRO industry regulations, standards, and guidelines (GLP, CSV, 21 CFR Part 11, and EU Annex 11).

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.

Customer Focus - Responds to customer's needs in a manner that provides added value and generates significant customer satisfaction.

Compliance - Applies an understanding of legal precedents, policies and practices to protect the interests of the organization.

Cross-team Collaboration - Ensures integration and cooperation across organizational boundaries.

Service Development, Delivery, Refinement and Quality - Manages service delivery to ensure high levels of customer impact and satisfaction. Constantly focuses on the continuous improvement of services and processes.

Physical Demands

This position primarily requires working in an office setting using a computer for extended periods. Occasional travel to Birmingham, AL if working remotely.

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.

Equal Employment Opportunity Statement

Southern Research is committed to providing equal employment opportunities to all individuals, regardless of race, color, national origin, ancestry, gender, sex, age, disability, religion, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by federal, state, or local laws.

We are an equal opportunity employer and seek to create a diverse and inclusive workplace. Our hiring, training, promotion, and compensation practices are based on the principles of fairness, equality, and merit.

Southern Research prohibits discrimination or harassment of any kind, including harassment based on any protected characteristic. We are committed to maintaining a work environment where all individuals are treated with respect, dignity, and fairness.

In addition, we provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state laws. We also offer support for individuals who require accommodations due to religious practices or beliefs.

If you have any concerns about discrimination or harassment, please contact humanresources@southernresearch.org immediately. We are committed to investigating all concerns thoroughly and promptly and taking appropriate corrective action when necessary.