Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Milpitas, California, United States of America
Job Description:
Johnson & Johnson is currently recruiting for a Senior Document Control Specialist, Quality Assurance. This position will be located in Milpitas, CA.
Position Summary
The Senior Document Control Specialist, Quality Assurance is responsible for administering, maintaining, and monitoring 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 serves as a subject matter expert for document control processes, supports continuous improvement initiatives, and partners with cross-functional teams to ensure the integrity, accuracy, availability, and compliance of controlled quality records and documents.
Essential Duties and Responsibilities
- Administer, maintain, and monitor document control, training, and change control processes in compliance with FDA/QSR, ISO 13485, company procedures, and applicable regulatory requirements.
- Ensure the accurate and timely review, approval, release, distribution, implementation, retention, and archival of controlled documents and quality records.
- Manage document changes, periodic reviews, document lifecycle activities, and controlled document repositories within electronic systems such as Agile and SAP.
- Coordinate and support Technical Review Board (TRB) meetings, change control activities, and other special projects related to document control and quality systems.
- Track, monitor, and report on document control performance metrics, including monthly and quarterly KPI reporting, periodic review status, change request backlog, document cycle times, and training compliance metrics.
- Participate in cross-functional teams to support product launches, process improvements, and quality system initiatives.
- Serve as a subject matter expert for document control processes and provide guidance and training to employees on document management systems, procedures, and compliance requirements.
- Author, revise, and maintain SOPs, work instructions, forms, and other controlled documents to ensure accuracy, consistency, and regulatory compliance.
- Monitor document control processes and identify opportunities for continuous improvement, standardization, and harmonization across sites and functions.
- Support internal audits, external audits, and regulatory inspections by preparing, organizing, and providing required documentation and records.
- Coordinate filing, storage, retrieval, retention, and disposition of controlled documents and records, including off-site storage when applicable.
- Communicate compliance risks, business issues, and process improvement opportunities to management and relevant stakeholders.
- Ensure adherence to company policies, quality standards, safety requirements, and environmental regulations while supporting departmental and organizational objectives.
- Perform additional duties and special projects as assigned in support of Quality Assurance and Document Control operations.
Qualifications:
Education:
A minimum of a Bachelors or equivalent University degree is required, with a focus in a scientific, engineering, business, or related discipline preferred. Equivalent combination of education and relevant experience may be considered
Required Skills & Capabilities:
- 5+ years of experience in document control ( Specifically Agile, WindChill), quality systems, records management, or a related quality assurance function within a regulated industry.
- Medical device, pharmaceutical, biotechnology, or life sciences industry experience preferred.
- Experience with electronic document management systems and training management systems required.
- Experience supporting FDA and ISO 13485 regulated environments preferred.
- Strong knowledge of FDA Quality System Regulations, ISO 13485, document control, and change control requirements.
- Working knowledge of Agile PLM, SAP, and electronic quality management systems.
- Understanding of product configuration management and product lifecycle documentation.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office applications.
- Ability to collaborate effectively across functions and organizational levels.
The anticipated base pay range for this position is :
$91,000.00 - $147,200.00
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 year
Sick 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 year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
