Sr. Application Administrator

About the role

The Sr. 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 Veeva Quality Vault and a subset of other GxP applications/systems used across multiple departments such as Quality, Toxicology, Bioanalytical, and/or Facilities.

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 and SaaS deployments.
• 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.
• 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

• Bachelor’s degree in computer science or life sciences, other related field, or equivalent experience.
• 8+ 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 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.
• Autonomous, proven leadership and mentoring responsibilities. 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.
• Experience supporting other laboratory systems (E.g., SoftMax Pro, 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 (GxP, CSV, 21 CFR Part 11, and EU Annex 11).