Process Documentation Specialist
Cook Medical
Date: 1 week ago
City: Bloomington, IN
Contract type: Full time
Overview
The Process Documentation Specialist supports the team for both process documentation as well as validation documentation. This role works with Process owners to document, implement and update CMH processes, as well as assisting team members with the creation and execution of the validation documentation.
Responsibilities
The Process Documentation Specialist supports the team for both process documentation as well as validation documentation. This role works with Process owners to document, implement and update CMH processes, as well as assisting team members with the creation and execution of the validation documentation.
Responsibilities
- Assist in monitoring and developing improvements and changes to internal team processes
- Lead the team in the completion and execution of Validation documentation
- Complete internal review of documentation, both process and validation, for completeness and accuracy
- Developing and maintaining a documentation library
- Establish and track milestones and deliverables
- Maintain an understanding of relevant global procedures
- Facilitate team adoption of processes, both organizational processes as well as internal team processes
- Collaborate with other Cook functional units (IT, Quality, Corp Ops etc) as needed for both processes and validation
- Identify opportunities for efficiencies
- Coordinate multiple projects at one time and provide regular reports to management
- Work with Management to support and identify issues that require immediate action
- Must strictly adhere to safety requirements
- Maintain regular and punctual attendance
- Must maintain company quality and quantity standards
- Must have effective oral, written and presentation communication skills
- Ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to remain calm and receptive in fast paced situations
- Associates degree or Bachelor's preferred or experience of such kind and amount as to provide a comparable background
- Experience with SDLC in a regulated industry
- Proficient in Microsoft Office applications
- Proficient in reading, writing, and speaking the English language
- Experience in global coordination of projects
- Works under general office environment conditions
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
- Requires occasional early morning or late evening teleconferences
- International and domestic travel as required
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