Documentation Specialist

1 month ago

Kennesaw, United States CryoLife Full time
Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website,www.artivion.com.

Position Overview:

To assist with management and control of all Artivion documents maintained in the Documentation System and administrative functions of the eQMS module. Ensure compliance to all internal procedures and external regulatory requirements. To ensure that all areas outlined under "Principal Responsibilities" are accomplished in an efficient, professional manner to support Artivion, Inc.

Responsibilities:

  • Manage the documents throughout the process to ensure an efficient and timely completion.
  • Lead the development and revision of department procedures and Work Instructions.
  • Provide guidance on any training program development as relevant to Document Control processes.
  • Perform editorial, word processing, and proofreading functions to ensure the accurate creation and revision of documentation.
  • Confirm documents entered in the eQMS Documentation system are checked for legibility, completeness and changes appropriately listed with rationale.
  • Verify documents routing have all appropriate approvers.
  • Monitor the status of document periodic reviews, initiations, and changes to ensure timely completion.
  • Assist in providing copies of documents as requested.
  • Manage the archiving and retrieval of documents.
  • Confirm superseded/obsoleted documents are not available to users.
  • Assist in managing projects and provide periodic status reports as necessary, including any global project teams.
  • Serve as liaison with Project Management and IT departments, when assigned.
  • Provide feedback on system improvements for streamlined workflow.
  • Support management in functions with System Administrator for document control and training modules.
  • Recognize future challenges and establish activities that will solve those challenges while providing guidance in fostering strong communications and objective teamwork.
  • Interact with personnel in all areas regarding the Documentation and Training modules, working collaboratively to resolve any issues.
  • Create positions, roles, and courses in SmartSolve Document/Training Modules as requested.
  • Provide support for the annual review of all training plans and for annual and triennial competency assessments.
  • Pull any necessary training data/reports and provide metrics, including past due training.
  • Will effectively complete “other” functions that may be assigned.
Qualifications:
  • Associate degree or the equivalence of 2 years of job-related work experience.
  • Minimum of 2 years’ experience in a regulated industry with an in-depth knowledge document control.
  • Advanced hands-on experience with word processing, editorial, and proofreading functions.
  • Experience with electronic quality management systems and using QA software tools.
  • Strong analytical and problem-solving skills.
  • Excellent verbal and written communication skills, including business writing.
  • Working knowledge of current Good Manufacturing Practices, Good Tissue Practices, Tissue Banking Regulations, Quality System Regulations, and ISO Standards.

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