Descripción del Trabajo
The Documentation Control Specialist is responsible for maintaining a controlled electronic documentation management system, process and management for record retention, information services function, and the electronic records retention processes. Develops, prepares, and reviews required documentation such as SOPS, quality control plans, engineering documents, manufacturing instructions, and change authorization in accordance with internal and external company policy.
This role ensures maintenance of general compliance to regulations and standards. Develops and implements documentation systems. Developed and implements record retention systems. Proposes and implements change control processes. Leads the review and revision of procedures, specifications, and development/engineering forms. Provides input on quality control procedures and quality system documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Oversees the maintenance of the Quality Document Control process, including logging and filing of controlled documents, NCRs, and prints and specifications.
· Oversees the maintenance of the Quality Record retention process, including logging and filing of Quality Control samples.
· Develops, review, and implements new procedures work instructions, quality plans, and other documents.
· May process changes to exciting procedures, work instructions, quality plans, and other documents using available system tools.
· Revises, prints, and distributes controlled copies of quality plans, work instructions, and procedures.
· Partners with relevant functional departments in completing all project and divisional training and documentation requirements.
· Ensures that aspects of the quality system that they are responsible for are performing in compliance with requirements.
· Oversess control of SOPS, cGMP, EN ISO 13485, EN ISO 9001, 21 CFR 820/201/211, and FDA/Regulatory requirements of the Quality System
· Takes personal accountability for one’s own safety.
· Supports culture of safety management through compliance with all safety policies, safety observation reporting, and proactive involvement in specific programs.
· May perform other duties and responsibilities as assigned.
· Attention to detail.
· Strong technical writing, documentation, and organization skills