Quality Systems (QS) Specialist

Southern Research Institute

United States, Alabama, Birmingham

May 29, 2025

Position:
Quality Systems (QS) Specialist

Location:

Birmingham, AL

Job Id:
4325

# of Openings:
1

The Quality Systems (QS) Specialist is responsible for providing oversight and guidance for the execution of quality processes within the Quality Management System (QMS) as part of the QS group. The QS Specialist will ensure that all quality processes (Deviation/CAPA, Training Administration, Document Control, GLP Archives) are conducted in compliance with applicable regulations, client requirements, and Southern Research procedures and policies. They support working relationships with other department staff and personnel to drive operational efficiencies a continuous improvement mindset.

This position may be remote, with occasional travel to Birmingham, AL.

MAJOR RESPONSIBILITIES

Guides the execution of Quality Event Reporting, Investigations, Corrective and Preventive Action (CAPA) program and Change Control processes.
Supports the Quality Review Board (QRB) for quality event awareness, discussion, and action plan development, including trend analysis and reporting.
Participating in the planning, development, creation, and implementation of training programs
Maintaining up-to-date, correct, and accurate training records
Oversees the controlled document process using the electronic Quality Management System (Veeva QualityDocs)
Prepares Document Change Controls and monitors through completion
Acts as a Leader of Influence and a trusted Point of Contact for Operations staff
Maintains a thorough knowledge of all applicable regulations and Southern Research policies.
Supports project deliverables, discusses project quality with management.
Ensures QS procedures, and policies are followed.
Supports the quality processes training program for CRO Operations, promoting organization awareness to foster a quality culture.
Assists with implementation and maintenance of the electronic QMS, providing business administration oversight and engagement where needed.
Demonstrates ownership of assignments with accountability and instills trust in project team.
Action and solution oriented with demonstrated problem-solving skills.
Demonstrates risk assessment skills and contributes to the development of management initiatives.
Established internally as a quality subject matter expert.
Leads process/continuous improvement efforts.
Executes change management through use of effective strategies and own skills in order to facilitate organizational change initiatives.

THE FOLLOWING IS REQUIRED

Experience with Veeva or comparable eQMS
Experience supporting operational excellence and continuous improvement through investigational skills, CAPA, effectiveness checks, and quality event trending/reporting.
Must have proven experience leading investigations in a Nonclinical Laboratory Research Organization.
Bachelor's degree
Strong team player with the ability to work across multiple disciplines.
Effective communicator (verbally and in writing) and self-starter.
Ability to handle multiple tasks simultaneously.
Must be able to do work independently, recognizing what needs to be done and accomplishing it with minimal supervision.
Experience working as a quality professional under 21 CFR 58 and 21 CFR 11.
2-5 years of experience in a quality assurance program or an equivalent combination of education and/or experience in a related field such as nonclinical research operations.

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 world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though 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 don't 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

Relationship Orientation - Develops positive relationships by making others feel their concerns and contributions are important.

Continuous Learning - Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning.

Tolerance for Stress, Ambiguity & Change - Demonstrates flexibility in applying different approaches to changing work demands.

Effective Communication - Creates a team environment in which information flows freely and decision making is based on a win-win philosophy.

Customer Focus -Responds to customer's needs in a manner that provides added value and generates significant customer satisfaction.

Compliance - Applies an understanding of legal precedents, policies and practices to protect the interests of the organization.

Cross-team Collaboration - Ensures integration and cooperation across organizational boundaries.

Service Development, Delivery, Refinement and Quality - Manages service delivery to ensure high levels of customer impact and satisfaction. Constantly focuses on the continuous improvement of services and processes.

Physical Demands

This position is required to work in an office setting using a computer for extended periods of time.
Occasional lifting

Certifications, Licenses & Registrations

None required

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