Job Description

: To assure that the Artemis Plastics documentation is maintained according to our policies and procedures to support our Quality Management System (QMS). Primary Functions • Responsible for cataloging assigned Controlled Documents, scanning, filing the digital files in the Document Management System, and retrieving respective documents

• Responsible for organizing and maintaining the records system as it relates specifically to Device History Records and other key documentation
• Assist in developing and maintaining validation activities and related documentation
• Assist QA Manager in the process of updating documents (which may involve requesting input from people at all levels and holding them accountable for prompt replies), as well as comfortability working autonomously
• Maintain assigned documents in the data management system to capture all requirements, maintain the files, assure quality, control revisions and final versions of all respective assigned documents

• Identify ways to streamline and/or enhance the efficiency of the document control process • Assist with system automation • Perform other duties as assigned

• Advise Quality Assurance Manager on findings that pertain to quality items
• Update job knowledge by participating in educational opportunities, reading technical publications, etc
• Follow regulatory requirements as they pertain to assigned job responsibilities
• Work well with others

Ideal candidate for the Document Control Specialist position would have some college courses, and/or be pursuing a college degree in a related field (Business, Quality Assurance, Law, Regulatory Affairs, etc), or extensive document control experience (i.e., medical record retention, para-legal documentation control, etc) • Awareness of Quality Management Systems and related software (IQMS and/or SAP) Great attention to detail, highly organized, logical, and methodical

• Very proficient in MS Office applications (Word, Excel, PowerPoint, etc)
• Able to effectively communicate (speak, read, write) in English
• Must be detail-oriented, and able to work with minimum supervision
• Must be able to work cooperatively in a team environment
• Detailed knowledge of computers, word-processing and spreadsheet software required

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