Overview
Quality & Regulatory Specialist Jobs in United States at Kelly Science, Engineering, Technology & Telecom
Title: Quality & Regulatory Specialist
Company: Kelly Science, Engineering, Technology & Telecom
Location: United States
Quality & Regulatory Specialist
Remote/Hybrid
Nashville, TN
The Quality & Regulatory Specialist plays a crucial role in maintaining the integrity of the Company’s proprietary diagnostic tests. Reporting to the Sr. Director, Quality and Regulatory, this position is responsible for overseeing and managing quality and regulatory processes and documentation. Key areas of focus include document control, training, and providing comprehensive quality and regulatory support for both operations and pharma services.
· Lead activities related to the following:
o Change Management
o Document Control
o Records Management
o Training: Assist Managers with creating and maintaining training plans and records.
o Management Review
· Assist in the development and implementation of inspection readiness and support senior staff during regulatory inspections or other audits.
· Promote awareness of applicable regulatory requirements, including QMS requirements and customer requirements throughout the organization.
· Assist in the execution of efficiency improvement projects and other administrative tasks for the department and company, as needed.
· Participate in all QA & RA programs, procedures, and controls to ensure product processes conform to established standards and agency guidelines.
· Perform other tasks as assigned.
Lead Activities for Regulatory Processes:
· MLR Document Approval
· External Standards
· Assist with submission projects in conjunction with contributing departments.
· Assist with other regulatory activities and submission publishing as needed.
Coordinate Activities for Quality Processes:
· Supplier Quality
· Corrective and Preventive Actions (CAPA)
· Internal Audits
Participate/Assist in Quality and Regulatory Processes:
· Risk Management
· Complaint Investigations
· Regulatory Documentation
eQMS System Management:
· Lead the development and implementation of the eQMS system.
· Manage software requirements and configuration based on company needs and quality/regulatory requirements.
· Collaborate with project managers and departmental leads to evaluate new solutions, upgrades, and add-on tools.
· Solve user challenges related to documents, provide templates, and correct user errors.
· Create accounts for all new hires and terminations.
· Ensure all new hires complete required onboarding training.
Job Qualifications:
· Bachelor’s degree or equivalent experience.
· 2 years of QMS experience working in a regulated, GMP environment/industry.
· At least 3 years of quality assurance, regulatory, and/or compliance experience within a regulated industry.
· Experience using Master Control software is preferred.
· Document review experience is required.
· Strong writing skills, with the ability to present findings in a clear and concise manner.
· Proficient in Excel, demonstrating competency in creating graphs, metrics, and trending using Excel functions.
· Experience with eQMS / ERP systems is preferred.
Job Details:
· Work Schedule: M-F; 8am-5pm (Subject to Change)
· Temp-to-Hire
· Remote/Hybrid
