Apply on Employer Site

Southern Research · 1 month ago

Quality Systems Specialist

Greater Birmingham, Alabama Area

Full-time

Onsite

Entry, Mid Level

2+ years exp

Southern Research is an organization that has been translating science into real-world solutions since 1941. The Quality Systems Specialist is responsible for overseeing quality processes within the Quality Management System, ensuring compliance with regulations and internal policies, and supporting operational efficiencies through collaboration with other departments.

BiotechnologyLife ScienceOncology

No H1B

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

Qualification

Veeva eQMSTraining ManagementDocument ManagementOperational ExcellenceContinuous ImprovementMulti-taskingQuality Assurance Experience21 CFR 5821 CFR 11Effective CommunicationTeam Player

Required

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