Southern Research · 18 hours ago
Sr. Application Administrator
Southern Research is a company dedicated to translating science into real-world solutions since 1941. They are seeking a Sr. Application Administrator responsible for supporting the implementation and maintenance of enterprise and laboratory systems, specifically Veeva Quality Vault and other GxP applications. The role includes user access management, system configuration, compliance support, and acting as a point of contact for software applications.
BiotechnologyLife ScienceOncology
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
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
Qualification
Required
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
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)
Benefits
Medical
Dental
Vision
401(k) match
Life insurance
PTO
An employee assistance program
And more
Company
Southern Research
A non-profit biomedical sciences research organization specializing in oncology, infectious disease, and neuroscience.
Funding
Current Stage
Growth StageTotal Funding
$9.89MKey Investors
US Department of Commerce, Economic Development AdministationU.S. Environmental Protection AgencyUS Department of Energy
2023-11-09Grant· $0.75M
2023-10-23Grant· $0.44M
2019-10-14Grant· $2.8M
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