Quality Systems Records Coordinator

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Robotics and Digital is recruiting for a Quality Systems Records Coordinator located in Santa Clara, CA.

The Quality Systems Records Coordinator will coordinate the RAD program to ensure compliance with the Worldwide Records and Information Management (WWRIM) Enterprise Standards, they will manage the retention of job descriptions and resumes and support Quality Management System training.

Key Responsibilities:

• Implement procedures and lead all aspects of the Records and Information Management (RIM) process.
• Provide direction and oversight to business partners on the appropriate way to handle records and data.
• Coordinate with Document Storage providers.
• Make training assignments and TRIP ticket resolution.
• Manage Job Description and CV process for Full-Time and contingent workers.
• Streamline training curricula, assign training and help support TRIP tickets as needed.
• Support FDA, Health Authority and Notified Body inspections conducted at Auris RAD sites, including readiness activities and front- and back-room participation.

Qualifications:

Education:

• Bachelor’s or equivalent university degree is required

Experience and Skills:

Required:

• A minimum of 5 years of proven experience in a regulated environment (medical device or pharmaceutical)
• Previous experience as a Records Manager handling the retention of documents and data for organizations including Quality, Legal, Human Resources and EH&S.
• Coordination of departmental records administration representatives.
• Previous implementation of a corporate records management program.
• Support of one or more Learning Management Systems (LMS), including working knowledge in an administrative role is required. 
• Understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to records retention and training is required.
• Must be a customer-focused, empathic individual who builds and maintains relationships with key business partners.
• Advanced organizational skills, consistent attention to detail, and the ability to balance multiple assignments is required.

Preferred:

• Experience in the configuration, validation, and implementation of an LMS, particularly experience with a SaaS model.
• Experience with Compliance Wire.

Other:

• Hybrid work schedule – with a minimum of three (3) days per week on-site at the Santa Clara, CA location. 
• Up to 10% travel may be required

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 https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis

 

 

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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