Quality Systems Specialist

Southern Research Institute•Birmingham, AL

37d

About The Position

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. 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 (Training Administration, Document Control, Deviation/CAPA) 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.

Requirements

Experience with Veeva or comparable eQMS.
Experience with Training & Document Management.
Experience supporting operational excellence and continuous improvement.
Bachelor's degree.
Strong team player with the ability to work across multiple disciplines.
Effective communicator (verbally and in writing) and a self-starter.
Ability to handle multiple tasks simultaneously.
2-5 years of experience in a QA program or an equivalent combination of education and/or experience in a related field such as nonclinical research operations.

Nice To Haves

Experience working under 21 CFR 58 and 21 CFR 11.

Responsibilities

Guides the execution of Training & Document Management Program within Veeva Quality.
Act as business administrator for eQMS, Veeva Quality for Document Management and Training Management.
Support system health and support system changes as needed.
Develop, maintain, and update the Training Matrix including Learner Role, Curricula, Training Requirement management.
Partner with functional areas to develop training plans.
Manage the controlled document lifecycle, ensure all documents follow proper workflows, version control rules, formatting standards, and naming conventions, ensuring document distribution is controlled and records are managed.
Supports the Quality Review Board (QRB) for Training & Document Program by generating metrics and dashboards for leadership.
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 Preclinical Services, promoting organization awareness to foster a quality culture.
May support Quality Event Reporting, Investigations, Corrective and Preventive Action (CAPA) program and Change Control processes.