Document Management Specialist

Johnson & Johnson • West Chester, MA

3d • Hybrid

About The Position

The Document Management Specialist will play an important role in executing the change control processes for changes to Device Master Records, Quality System Record data, and/or documents in the PLM system (Windchill), providing internal customers with guidance in following change control procedures. You will be responsible for executing change control processes related to the change control oversight of DePuy Synthes processes, including reviewing changes in a timely manner for compliance with procedures, selecting or verifying approvers of changes per procedures, collecting and reporting metrics pertaining to change control activities, and communicating the status of changes. You will also manage small projects that help support departmental objectives, including projects that require collaboration with other departments or facilities, support and recommend change control process improvements, and support both internal and external audits, as well as quality events, relating to the change control processes. Ensure all activities are in compliance with the documented quality system and current regulatory requirements.

Requirements

• University/Bachelors Degree (or equivalent 4 year degree) plus a minimum of 1 year with electronic change control experience in regulated industry – medical device or pharmaceutical industry preferred OR Associate Degree (or equivalent 2year degree) plus a minimum of 3 years of business experience, including a minimum of 2 years with electronic change control experience in medical device or pharmaceutical industry OR A minimum of 5 years of business experience, including a minimum of 4 years with electronic change control experience in medical device or pharmaceutical industry
• Strict attention to detail and the ability to work in an open office environment and remotely with virtual teams
• Able to organize, prioritize, and handle multiple projects simultaneously
• Able to work independently and prioritize with little supervision
• Strong written and verbal communication and teamwork skills
• Proficient in Microsoft Outlook, Word, Excel, and PowerPoint

Nice To Haves

• Proficient in change control processes and Product Lifecycle Management systems - experience with Agile e6, ADAPTIV (Enovia platform), and/or Windchill PLM applications highly desired

Responsibilities

• Executing change control processes related to the change control oversight of DePuy Synthes changes
• Reviewing changes in a timely manner for compliance with procedures
• Selecting or verifying approvers of changes per procedures
• Collecting and reporting metrics pertaining to change control activities
• Communicating the status of changes
• Manage small projects that help support departmental objectives, including projects that require collaboration with other departments or facilities
• Support and recommend change control process improvements
• Support both internal and external audits, as well as quality events, relating to the change control processes
• Ensure all activities are in compliance with the documented quality system and current regulatory requirements.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree