Document Control Specialist

Position Summary The Document Control Specialist is responsible for supporting the administration, maintenance, and monitoring of Quality Management System (QMS) documentation, training records, and change control activities in compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, company policies, and other applicable regulatory requirements. This role supports document control operations, assists with continuous improvement initiatives, and works with cross-functional teams to ensure the accuracy, accessibility, and compliance of controlled quality records and documents. Participate in cross‑functional teams to support product launch requirements and targets. Recommend and implement appropriate change control systems and processes to endure effective compliance to JJSV and external regulations. Adheres to environmental policy, procedures, and supports department environmental objectives. Key Responsibilities Support the administration, maintenance, and monitoring of document control, training, and change control processes in compliance with FDA/QSR, ISO 13485, company procedures, and applicable regulatory requirements. Process and maintain controlled documents and quality records, ensuring accurate and timely review, approval, release, distribution, implementation, retention, and archival. Support document changes, periodic reviews, document lifecycle activities, and management of controlled document repositories within electronic systems such as Agile and SAP. Coordinate documentation activities and support Technical Review Board (TRB) meetings, change control workflows, and document control‑related projects. Collect, compile, and prepare monthly and quarterly document control metrics, including periodic review status, change request backlog, document processing cycle times, and training compliance data. Assist in tracking and monitoring document control performance indicators and communicate status updates to management and stakeholders. Participate in cross‑functional teams supporting product launches, process improvements, and quality system initiatives. Provide guidance and training to employees on document control procedures, document management systems, and approved quality system processes. Draft, revise, and maintain SOPs, work instructions, forms, and other controlled documents under the direction of Quality Assurance management. Support continuous improvement activities by identifying opportunities to improve document control processes, efficiency, and compliance. Assist with internal audits, external audits, and regulatory inspections by preparing, organizing, and retrieving controlled documentation and quality records. Coordinate filing, storage, retrieval, retention, and disposition of controlled documents and records, including off‑site storage activities when applicable. Communicate document control issues, compliance concerns, and process improvement. Qualifications Education: Bachelor’s degree in a scientific, engineering, business, or related discipline preferred. Equivalent combination of education and relevant experience may be considered. Experience: 2–5 years in document control, quality systems, records management, or a related Quality Assurance function in a regulated industry; experience in FDA and/or ISO 13485 environments preferred. Technical: Experience with electronic document management systems, Agile PLM, Windchill, SAP, or similar systems; basic understanding of FDA Quality System Regulations, ISO 13485, document control, and change control requirements. Skills: Strong organizational and time‑management skills; ability to manage multiple priorities and maintain attention to detail; effective written and verbal communication skills; proficiency with Microsoft Office applications; ability to work independently and collaboratively in a cross‑functional environment. Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson & Johnson is committed to providing an inclusive interview process and reasonable accommodations for applicants with disabilities. Compensation Anticipated base pay range: $75,000.00 - $120,750.00. Benefits Key benefits include Vacation (120 hours per calendar year), Sick time (40 hours per calendar year), Holiday pay (13 days per calendar year), and Parental Leave (480 hours within one year of birth/adoption). #J-18808-Ljbffr