JOB DESCRIPTION
Title: Document Control Coordinator
Reports to: Document Control Manager
ESSENTIAL RESPONSIBILITIES AND DUTIES INCLUDE:
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Assist Document Control Manager with Document Control PLM system in support of other departments, in accordance with policies and procedures
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Maintain continuity of digital files to ensure naming standards, appropriate file locations, format standardization
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Maintain company documentation, as required
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Internal reporting for various company system metrics
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Issue controlled Laboratory Notebooks to cross functional departments
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Assign VV numbers to cross functional departments
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Maintain all Quality Records from inception to archival as hard files/electronic files
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Ensure accuracy, quality, and integrity of all company documents
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Ensure easy and efficient retrieval of documents internally and externally
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Assist in updating device regulatory labels in label software
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Assist in training and maintain training with company training process within company PLM system and hard files
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Assist with Quality Audits
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Update and maintain Standards Database
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Scanning of Quality Documentation
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Ensure ethics and compliance commitment at all times
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Maintain confidentiality regarding sensitive documentation
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Review and update documents for maintenance and quality control with being audit ready as the goal
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Perform other TransMedics job-related tasks and duties, as assigned
BACKGROUND and QUALIFICATIONS:
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3-5 years’ experience working in a regulated industry; Quality Control experience strongly preferred
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Proficient with Microsoft office software
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Documentation Management Database experience preferred
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Strong organizational skills with the ability to work with a high degree of accuracy
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Attention to detail
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Exceptional proof reading and quality control skills
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Excellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the company
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Familiarity with a Quality Management System or other regulated environment and the ability to adhere to all processes and procedures
EDUCATION: