Sr. Application Administrator
Location
United States
Posted
3 days ago
Salary
Not specified
No structured requirement data.
Job Description
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.
- 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.
- 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.
- 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.
- 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).
- Operational / Technical Excellence – Ensures that work product (whether service or process) enables the organization to deliver on customers’ expectations.
- Builds Strategic Relationships – Uses appropriate interpersonal styles to work effectively with others to meet mutual goals and objectives; understands the role and interrelationships of each organizational function. Possesses skill in managing across functional and organizational lines.
- Drives for Results – Establishes stretch goals and manages to focus outcomes. Demands excellence. Demonstrates a strong commitment to organizational success; works to do what is best for all stakeholders.
- Change Agent – Seeks and encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitates the implementation and acceptance of change within the workplace.
- Contributes to Team Success – Contributes to a climate of teamwork to achieve objectives, taking advantage of our diversity; demonstrates and supports in others through actions a sense of ownership.
- Business Knowledge – Maintains external awareness of technology or business sectors; supplies knowledge of Institute’s culture, business processes and tools to achieve goals.
- Planning and Organization – Systematically identifies issues to be addressed and plans a course of action for self and engages others appropriately to ensure the accomplishment of specific objectives.
- Attention to detail – Utilizes established monitoring system, records data accurately and in a timely manner, and ensures accuracy of data.
- Technical Expertise – Possesses and applies professional/technical knowledge, skills, experience, and judgment to accomplish a result, serve customers better, and contribute to the organization’s intellectual capital.
- Continuous Learning – Targets learning needs; seeks learning activities; maximizes learning; applies knowledge or skill; and takes appropriate risks in learning.
- Quality Orientation – Follows procedures, ensures high-quality outputs, and takes action.
- Communicates with Impact – Expresses thoughts and ideas effectively in individual and group situations; adjusts language to the needs of the audience. Ideas are clearly defined in grammatically correct written communication.
- Individual Accountability – Empowered, results oriented, takes responsibility, consistently delivers on commitments.
- 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.
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.
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