Document Specialist

Audubon, PA

At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them. 

Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!

Position Summary:

The primary function of the Documentation Specialist will be to manage and organize all Quality Documentation that is required by Globus Medical and other regulatory agencies.  This will include issuing, maintaining, controlling, and auditing documentation that is required for Quality and cGMP compliance.

The responsibilities of the position include, but are not limited to, the following:

  • Coordinating, writing, and releasing document change orders with inputs from other functional areas
  • Communicating the impact of document change orders across functional areas
  • Ensuring documentation is complete, properly formatted and meets corporate standards
  • Assisting Director-QA in assigning and tracking new part and document numbers through the development cycle
  • Assisting in the creation of Customer private labeling materials and specifications (Labels, IFU, boxes, packaging specifications)
  • Performing database searches, data analysis, and reporting to assist in development activities
  • Utilizing multiple manufacturing business systems, spreadsheets, graphs, word processors and product information management systems in order to facilitate the release, change, data storage & retrieval processes including the maintenance of a Document, Form & Regulations Reference Matrix
  • Maintaining the Employee Training System and related documentation
  • Organizing and Leading Quarterly plant wide documentation audit. Manage follow-up list from the audit
  • Assisting in conducting various training classes relating to documentation practices that pertain to Quality on an as needed basis
  • Assisting with the day-to-day functions of the Quality area
  • Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
  • Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

In order to be qualified for this role, you must possess the following:

  • High School Diploma; Associate’s degree preferred
  • 5 years GMP/FDA experience
  • Strong interpersonal and communications skills; ability to develop and express ideas
  • Responsiveness to changing business conditions and customer needs
  • Ability to multi-task in a fast-paced environment
  • Proficient organizational, typing and writing skills with an attention to detail
  • Strong computer skills in Microsoft Office systems, scanning, archiving, and transmitting of electronic information
  • Proven Auditing Skills

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

JOB CODE: 1001590