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 Documentation

Job Category:

Professional

All Job Posting Locations:

West Chester, Pennsylvania, United States of America

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

We are searching for the best talent for Document & Change Control Admin.

You will be responsible for:

• Accountable that Synthes Change Requests (CR) and Change Notices (CN) are reviewed for completeness, accuracy and compliance with applicable policies and procedures.  Performs the Change Admin I, Change Admin II, and Change Admin III roles in the Windchill PLM system.
• Communicate CR/CN status information as requested.
• Maintain accurate records of key process data related to CR/CNs, as directed by management.
• Support the Periodic Review process for controlled Quality documents.
• Provide historical and current documentation in response to audits, legal requests, queries from management and other departments as needed.
• Provide document and change control backroom and logistical support for audits and inspections as needed.
• Assists in creating, maintaining, and implementing departmental work instructions and associated documentation and system configurations related to document and change control processes and other quality systems, to ensure conformance to regulatory, program, and internal customer requirements, and to promote continuous improvement.
• Supports actions and effectiveness monitoring activities associated with CAPAs, NCs, observations, and other quality events related to document and change control processes.
  • Follow all relevant DePuy Synthes Work Instructions in the performance of tasks.
  • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

o    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

o    Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

o    Performs other duties assigned as needed

 

Qualifications / Requirements:

• University Bachelor’s Degree or equivalent is required.
• Minimum 3-4 years experience working in a GMP, ISO or similar regulated environment is required.
• Proficiency with Microsoft Office products (Word, Excel, Power Point, etc.) is required. 
• Proficiency in Windchill PLM is preferred.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Previous document control experience is strongly preferred.
• Medical device, Pharmaceutical and/or Biotech experience is preferred.
• Proficiency with various PC-Based CAD systems (Pro/Engineer, AutoCAD, etc.) is preferred
• Exhibit excellent organizational and verbal/written communication skills.
• Be an extremely flexible team player, adaptable to change.
• Be customer service oriented and experienced at interacting with individuals at all levels, including upper management.

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.

#LI-Onsite 

 

 

Required Skills:

 

 

Preferred Skills:

GMP Documentation, GMP Environments, PTC Windchill