What are the responsibilities and job description for the Quality Systems Specialist position at Southern Research?
Southern Research 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, 401(k) match, life insurance, PTO, an employee assistance program, and more.
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 (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.
Essential Duties & Responsibilities
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 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 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.
Physical Demands
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.
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, 401(k) match, life insurance, PTO, an employee assistance program, and more.
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 (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.
Essential Duties & 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.
- 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.
- Experience working under 21 CFR 58 and 21 CFR 11.
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 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 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.
Physical Demands
- This position is required to work in an office setting using a computer for extended periods of time.
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.
