Quality Systems Specialist
About The Position
Johnson & Johnson is seeking a Quality Systems Specialist for its new Biotherapeutics Manufacturing facility in Wilson, North Carolina. The role 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 reviews, and annual product reviews. The specialist serves as a subject matter expert and partners with departments to help ensure quality and compliance goals are met in accordance with J&J standards and regulatory requirements. The position administers electronic quality systems and document and records management processes. This includes processing document submissions and access requests, reviewing documents for compliance with site requirements, coordinating review and approval workflows, managing system users and privileges, tracking documents, generating reports, and supporting system upgrades and continuous improvement. The specialist also supports site deviation, change control, training, and document management systems under the guidance of the Quality Systems Manager. Additional responsibilities include supporting quality assurance activities, management reviews, annual product reviews, validation compliance, quality metrics, inspection readiness, and GMP and Good Documentation Practice training. The specialist develops and maintains training materials, coordinates periodic GMP document reviews, manages records retention and archival, and serves as a delegate for the Quality Systems Manager when appropriate. The role 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
- Lead and/or support site quality systems, including document management, training, deviations/CAPAs, audits, change controls, gap assessments, specifications, quality agreements, quality management reviews, and annual product reviews.
- Serve as a Quality Systems subject matter expert for the Wilson manufacturing site.
- Facilitate and/or support the Change Control Board, Change Control Review Board, and CAPA Review Board.
- Provide support and direction to departments on quality system elements and document control.
- Partner with departments to complete quality systems and programs efficiently and compliantly.
- Manage document control and records management for SOPs and other GMP-regulated documents, including receiving submissions, reviewing them for conformance, coordinating approval schedules, and providing feedback to document owners.
- Administer relevant local and global quality systems and process personnel access requests and privileges.
- Provide feedback to global process owners regarding continuous improvement to quality systems.
- Administer the site's Electronic Document Management System, including managing users and privileges, configuring review and approval routings, tracking documents, generating reports, supporting upgrades, and developing related procedures.
- Administer site deviation management, change control management, and training systems using an Electronic Tracking System.
- Assist Quality Assurance with specifications, quality agreements, and gap assessments.
- Support management reviews, documentation management, annual product reviews, and validation compliance activities as needed.
- Manage assigned Quality Systems metrics and support implementation of quality policies, procedures, and systems.
- Provide or support GDocP and GMP training and develop and maintain training materials.
- Support inspection readiness at the site, including as a documentation and records management subject matter expert.
- Prepare and catalogue documents for archival, coordinate archival with internal and external groups, manage document retrieval, regulate access to on-site storage, and audit document storage/archive systems.
- Partner with Learning & Development to provide GDocP and GMP training.
- 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.
- Perform related duties assigned by the supervisor and maintain compliance with company policies and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
