Quality Systems Specialist

Johnson & Johnson • Wilson, NC

5d • Onsite

About The Position

Johnson & Johnson is seeking a Quality Systems Specialist for its new Biotherapeutics Manufacturing facility in Wilson, North Carolina. The position leads and supports quality systems across the site, including document management, training, deviations and CAPAs, audits, change controls, gap assessments, specifications, quality agreements, quality management review, and annual product reviews. The role provides quality-system expertise and direction to departments, supports compliant and efficient program execution, and helps ensure alignment with company standards and regulatory requirements.

The specialist administers document and records management processes and electronic quality systems, including user access, document routing, review and approval tracking, reporting, and system upgrades. The position also supports deviation, change-control, and training systems; manages quality-system metrics; develops and delivers Good Documentation Practice and GMP training; coordinates documentation reviews and records retention; and prepares, retrieves, and audits archived records. The role supports inspection readiness and may act as a delegate for the Quality Systems Manager when appropriate. This position is onsite.

Requirements

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• At least 2 years of experience working in Quality and/or Compliance in the pharmaceutical industry.
• At least 2 years of experience managing workflows within electronic quality systems such as Track Wise, Master Control, Veeva, Compliance Wire, Success Factors, ZenQMS, or Documentum.
• At least 2 years of experience leading or managing quality-system elements, including deviations/nonconformances, change controls, training, documentation, annual product reviews, and gap assessments.
• Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals, and ability to apply GMP regulations and other FDA and international guidelines.

Responsibilities

• Serve as a Quality Systems subject matter expert for the Wilson manufacturing site.
• Facilitate or support the Change Control Board, Change Control Review Board, and CAPA Review Board.
• Provide departments with support and direction on quality-system elements and document control in accordance with company standards.
• Partner with other departments to complete quality systems and related programs efficiently and compliantly.
• Manage document control and records processes for SOPs and other GMP-regulated documents, including receiving, logging, reviewing, routing, tracking, and providing feedback on documents.
• Administer access to electronic quality systems and provide feedback to global process owners about continuous improvement.
• Administer the site Electronic Document Management System, including adding users, assigning privileges, setting up review and approval routings, tracking documents, generating reports, and participating in upgrades.
• Administer site deviation management, change control management, and training systems using an Electronic Tracking System.
• Assist with specifications, quality agreements, and gap assessments.
• Support Quality Systems Management Review, documentation management, annual product review, and validation compliance activities as needed.
• Manage assigned Quality Systems metrics and support implementation of quality policies, procedures, and systems.
• Provide or support Good Documentation Practice and GMP training, and develop and maintain training materials.
• Support site inspection readiness, including serving as a documentation and records management subject matter expert.
• Prepare and catalogue documents for archival; coordinate archival with internal and external groups; retrieve records; regulate access to onsite storage; and audit internal and external storage and archive systems.
• Coordinate periodic review of GMP documentation and manage the record retention program in accordance with global and local requirements.
• Serve as a delegate for the Quality Systems Manager when appropriate and perform related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level