Job description:
the documentation specialist plays a pivotal role in the electronic documentation system.
they collaborate with stakeholders to create high-quality documents that align with established standards.
by leveraging their expertise, they contribute to achieving departmental and plant goals.
key responsibilities:
* develops documentation strategies
* processes change requests for administrative routes
* ensures project document release in the mastercontrol system
* designates mfg and waiver numbers
* provides technical advice on quality systems to other departments
* manages project data inputs
* coordinates approval panels
* creates dmr and bmd document control numbers
* consults obsolete documents in mastercontrol and legacy
* trains employees from document control and new power users
* participates in design, development, and implementation of documentation systems and projects management
* assists in fulfilling departmental and plant goals for continuous improvement and supporting divisional and corporate goals
* participates in implementing quality programs promoting prevention and no detection of defects or problems
* collaborates with engineering, production, quality, etc. in document development and project completion
* participates as internal auditor in verifying quality system compliance with iso 13485:2016 and qsr/gmp regulations and internal policies
* proposes changes for process, product, and method improvements
* elaborates and revises documents in general
* represents the organization in meetings and represents the department in projects or other departments
* participates in planning, implementation, following, or evaluation of goals or department projects
* implements lean manufacturing/lean thinking tools
* works with translators in assigning tasks and coordinating changes
* develops visual system maps (vsm) and proposes improvements