General Summary
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.
Key Responsibilities
* Performs all duties of GLP Archivist in accordance with 21CFR58.190
* 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, manuals, 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.
Position Specific Requirements/Minimum Qualifications:
* 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 with eQMS Platform
* Proven track record in FDA-regulated environments
Preferred Qualifications
* 2-5 years of experience in a quality assurance program and proven communication skills; or an equivalent combination of education and/or experience in a related field.
* Experience supporting operational excellence and continuous improvement through investigational skills, CAPA, effectiveness checks, and quality event trending/reporting.
* Experience working as a quality professional under 21 CFR 58 and 21 CFR 11.
* Experience with Veeva
|
Southern Research Institute
May 12, 2025 