Sr. Application Administrator

Southern Research Sr. Application Administrator Remote

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, 401k match, life insurance, PTO, an employee assistance program, and more.

General Summary

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

The Sr. 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 Sr. 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

• 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 and communicate and work with applications/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 • Identify 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 meet 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: • Bachelors 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 deadlines • 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

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 worlds most powerful resource is human potential
• We are an inclusive and courageous team where innovation and diversity of thought 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 dont 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

• 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 Institutes 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 organizations 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

Physical Demands

• 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

Certifications, Licenses & Registrations

• None required
• 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