QMS Documentation Control (Temp Position)
Role and essential Responsibilities
Coordinates the review and revision of procedures, specifications and forms. Prepares process and status reports, assigns and monitors document numbers, reviews documents for accuracy and completeness and administrates the change control process. Assists in compiling and control of quality records, regulatory filing documents and maintaining computerized files to support all documentation systems.
Type the items expected to be performed for this position:
- Manage document workflow and ensure document control system compliance with internal procedures and external requirements.
- Maintain document tracking system.
- Issue and track document distribution.
- Edit Documentation, convert documentation to new company formatting.
- Process Change Requests, review documents for format, consistency and compliance with existing procedures; perform edits.
- Publish issue and maintain controlled documents.
- Maintain document and record archives and provide support for document system users.
- Scan and archive completed documents, notebooks, completed protocols, records and other documents.
- Organize and administer the flow of electronic and hard copy documents for all departments.
- Retrieving documents related to quality issues.
Qualifications and education requirements
Type a description of the work experience and educational background that is preferable for this position.
- AS or Bachelor’s Degree; or three (3) to five (5) years practical experience in Document Control, Information Technology, Training or quality in an FDA regulated industry; or equivalent combination of education and experience
- Effective planning and organizational skills and the ability to work with a high degree of accuracy and recall.
- Very detailed oriented.
- Ability to manage time and workflow efficiently.
- Practical knowledge of electronic documentation and/or data management systems.
- Excellent written and verbal communication skills.
- Effective interaction with peers and leadership across all departments.
- The employee is essentially in an office environment and at desk/workstation
- Must possess sight/hearing senses to adequately perform the functions of the job
- The employee is regularly required to verbally communicate
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus
- Must be able to manage and handle stressful and or demanding situations
Working relationships / Environmental Exposures
- Work is normally performed in a climate controlled office
- Noise level is moderate and includes sounds of a normal office environment
- Nor environmental hazards are encountered in performance of normal job duties
- Frequent contact with managers, training coordinator, QA personnel, and manufacturing personnel