Document & Change Control Admin

Johnson & Johnson • West Chester, PA

1d • Onsite

About The Position

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. 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

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.

Nice To Haves

• Proficiency in Windchill PLM is preferred.
• 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.

Responsibilities

• 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.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level