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Document Processor
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Description
Maintain proper document review processes
Reviews completeness of documentation
Ensures availability/publishing of controlled documents
Maintains document control files and records. Archives Device History Records, Lot History Records, Master Device Records, Training Records, Management Review etc
III. REQUIREMENTS:
EDUCATION:
•High-school/Associates degree or equivalent experience
KNOWLEDGE AND EXPERIENCE:
•Knowledge of computer applications (i.e.: Microsoft Word, Excel, PowerPoint, Access & Project, Windows, Visio, etc.) required
•Knowledge of regulated industries; familiarity with ISO 13485:2016, FDA Good Documentation Practices
•2 years of experience in Document Control
•Working knowledge of change management and document control processes
ADDITIONAL DESIRABLE QUALIFICATIONS:
•Document Control experience preferred
•Experience in a regulated industry preferred
SKILLS AND ABILITIES:
•Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties
•Strong attention to detail
•Ability to maintain confidentiality
•Organizational skills and ability to prioritize workflow to meet established timeframes
•Ability to maintain updated knowledge of procedures, products and activities of assigned area
•Ability to accurately proofread documents
•Demonstrated understanding of FDA Good Documentation Practices (GDP)
•Clear and effective communication skills
PROBLEM-SOLVING AND DECISION MAKING:
•Follows specific, detailed process instructions; ability to troubleshoot and problem solve effectively. Defers to supervisor when required.
Description
Maintain proper document review processes
Reviews completeness of documentation
Ensures availability/publishing of controlled documents
Maintains document control files and records. Archives Device History Records, Lot History Records, Master Device Records, Training Records, Management Review etc
III. REQUIREMENTS:
EDUCATION:
•High-school/Associates degree or equivalent experience
KNOWLEDGE AND EXPERIENCE:
•Knowledge of computer applications (i.e.: Microsoft Word, Excel, PowerPoint, Access & Project, Windows, Visio, etc.) required
•Knowledge of regulated industries; familiarity with ISO 13485:2016, FDA Good Documentation Practices
•2 years of experience in Document Control
•Working knowledge of change management and document control processes
ADDITIONAL DESIRABLE QUALIFICATIONS:
•Document Control experience preferred
•Experience in a regulated industry preferred
SKILLS AND ABILITIES:
•Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties
•Strong attention to detail
•Ability to maintain confidentiality
•Organizational skills and ability to prioritize workflow to meet established timeframes
•Ability to maintain updated knowledge of procedures, products and activities of assigned area
•Ability to accurately proofread documents
•Demonstrated understanding of FDA Good Documentation Practices (GDP)
•Clear and effective communication skills
PROBLEM-SOLVING AND DECISION MAKING:
•Follows specific, detailed process instructions; ability to troubleshoot and problem solve effectively. Defers to supervisor when required.
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