Application Administrator

Southern Research•Birmingham, AL

2h•Hybrid

About The Position

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.

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 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.

Nice To Haves

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).

Responsibilities

Provision user accounts, assign roles and manage permissions.
Setup and maintain application settings such as security, metadata, and workflows. Help build out studies and interfaces as appropriate.
Support validation activities, including but not limited to, testing, SOP authorship, and User Training.
Facilitate and drive change management activities (including configuration), as necessary.
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.
Function as the business and vendor point-of-contact for the system and SaaS deployments.
Maintain the system binder, ensure the documentation generated for the system is compiled, accessible, and audit ready.
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.
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.