Documentation Specialist - Hybrid (Kennesaw, GA)
CryoLife
- Kennesaw, GA
- Permanent
- Full-time
- 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- Confirm superseded/obsoleted documents are not available to users.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.
- 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.