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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Business Enablement/Support

All Job Posting Locations:

Grecia, Costa Rica

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Doc Control Technician.

Purpose:
The Doc Control Technician executes change-control activities for controlled documents within the document management system. This role additionally coordinates guidance to internal customers on how to execute the change control process and ensuring adherence to established standards.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Reviewing changes in a timely manner for compliance with procedures
• Review accuracy and consistency of document changes submitted, according to internal procedures.
• Selecting or verifying approvers of changes per procedures
• Collecting and reporting metrics pertaining to change control activities
• Manage projects that help support departmental objectives, including projects that require collaboration with other departments or facilities
• Support and recommend change management process improvements
• Support both internal and external audits, as well as quality events, relating to the change control processes
• Ensure all activities are following the documented quality system and current regulatory requirements
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

EXPERIENCE AND EDUCATION

• Technical Degree completed.  
• 2-4 years of business experience, including a minimum of 2 years with electronic change control experience in medical device or pharmaceutical industry

Required knowledge, skills, abilities, certifications/licenses and affiliations

• Bilingual or Fluent in English / Spanish desired
• Computer skills and proficiency in Microsoft Office (i.e., Word, Excel, PowerPoint, E-mail).
• Ability to learn software applications associated with Document & Data Control (Product Lifecycle Management - PLM system).
• Experience in Electronic change control processes and PLM systems (i.e., Windchill, ADAPTIV, etc.) in a regulated industry is highly desirable.
• GMP/ ISO knowledge preferred.
• Strong verbal, written and active listening skills.
• Ability to organize, prioritize, and handle multiple projects simultaneously.
• Ability to communicate effectively   and   in   a   professional   manner   with   all   levels   of   the organization and with different functional groups.
• Ability to perform duties in accordance with policies and procedures complying with applicable requirements.
• Ability to work collaboratively with a team or independently, with an eye for detail and methodical approach.

#RPOCRA #LI-ONSITE

 

 

Required Skills:

 

 

Preferred Skills:

Accountability, Administrative Support, Compliance Management, Data Gathering Analysis, Data Reporting, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Organizing, Process Oriented, Project Support, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Technical Writing, Time Management