Document Control Specialist

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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 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:

• Bachelors 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.

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