Document Control Specialist

Document Control Specialist, Quality Assurance

Johnson & Johnson is currently recruiting a Document Control Specialist, Quality Assurance! This position will be located in Milpitas, California.

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 ensure 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:

• Bachelor's degree in a scientific, engineering, business, or related discipline preferred.
• Equivalent combination of education and relevant experience may be considered.

Required Skills & Capabilities:

• 25 years of experience in document control, quality systems, records management, or a related Quality Assurance function in a regulated industry.
• Experience working within FDA and/or ISO 13485 regulated environments preferred.
• Experience with electronic document management systems, Agile PLM, Windchill, SAP, or similar systems preferred.
• Basic understanding of FDA Quality System Regulations, ISO 13485, document control, and change control requirements.
• Familiarity with electronic document management and training systems.
• 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.

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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $75,000.00 - $120,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation 120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar yearHoliday pay, including Floating Holidays 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave 80 hours in a 52-week rolling period10 daysVolunteer Leave 32 hours per calendar yearMilitary Spouse Time-Off 80 hours per yearFor additional general information on Company benefits, please go to: -

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