Senior Quality Systems Specialist

Advanced Recruiting Partners; Raleigh (NC); On-site; USD 90,000 - 125,000; Full time

Job summary

Advanced Recruiting Partners in Raleigh, NC seeks a Senior Quality Systems Specialist to support the QMS with emphasis on document control and training, ensuring compliance with FDA/GxP requirements.

The role collaborates with cross-functional teams to maintain controlled docs, manage EDMS/LMS workflows, audits, CAPAs, and supplier oversight in a regulated environment.

Qualifications

• Bachelor's degree in a scientific, technical, or related field is required.
• 5–7+ years of experience in Quality Systems within regulated industries (pharma/biotech/medical devices).
• Hands-on experience with electronic document management systems and LMS/eLMS.
• Strong understanding of document control processes and electronic documentation systems.
• Working knowledge of FDA regulations and GxP requirements.
• Strong communication, organizational, analytical and problem‑solving skills.

Responsibilities

• Document Control Support: manage creation, revision, routing, approval, and archiving of controlled documents (SOPs, forms, policies).
• EDMS workflows: ensure metadata, version control, and approvals are correctly handled.
• Audit readiness: maintain records and respond to auditor requests; assist with internal/external audits.
• QMS Support: assist CAPA, change control, deviations, training, and maintenance of QMS processes.
• Supplier oversight: maintain the Approved Supplier List and track supplier performance.

Skills

Quality Systems

Regulatory knowledge

Documentation

Communication

Analytical skills

Problem solving

Education

Bachelor's degree in scientific/technical field

Tools

EDMS

LMS/eLMS

Job description

The Senior Quality Systems Specialist provides advanced support across the Quality Management System (QMS), with a primary focus on Document Control and Training. This role ensures that quality processes are executed accurately, efficiently, and in accordance with applicable regulatory requirements and internal GxP standards. The position works collaboratively with cross-functional teams to maintain controlled documentation, training compliance, supplier oversight, and overall QMS effectiveness.

Key Responsibilities

Document Control Support

• Support the creation, revision, formatting, routing, approval, and archival of controlled documents, including SOPs, work instructions, forms, policies, specifications, and related quality records.
• Execute document workflows within an electronic document management system (EDMS), ensuring accurate metadata, version control, and appropriate approval routing.
• Assist with periodic document reviews and ensure documentation remains current, accurate, and audit-ready.
• Provide guidance to document authors and reviewers regarding document control procedures, standards, and best practices.
• Monitor document lifecycle metrics and identify or escalation issues as appropriate.
• Support supplier qualification and re-qualification activities, including collection, review and maintenance of required documentation.
• Assist with supplier audit scheduling and tracking of audit deliverables, observations and corrective and preventive actions (CAPAs).
• Maintain and update the Approved Supplier List (ASL).
• Support ongoing monitoring and documentation of supplier performance.

Quality Management System (QMS) Support

• Support the execution and maintenance of QMS processes, including CAPA, change control, deviations, training, document control and audit readiness.
• Assist with preparation for internal and external audits by gathering documentation, maintaining records and responding to auditor requests.
• Maintain QMS records to ensure accuracy, completeness, traceability and compliance with applicable regulatory expectations.
• Contribute to continuous improvement initiatives across the QMS, including process updates, template enhancements and system improvements.
• Support cross-functional teams in understanding and consistently applying QMS requirements and procedures.

Required

• Bachelor’s degree in a scientific, technical, or related field, or equivalent combination of education and experience.
• 5–7+ years of experience in Quality Systems within the pharmaceutical, biotechnology, medical device or other regulated industries.
• Hands‑on experience with electronic document management systems and learning management systems (LMS/eLMS).
• Strong understanding of document control processes and electronic documentation systems.
• Working knowledge of FDA regulations and GxP requirements.
• Strong communication, organizational, analytical and problem‑solving skills.