Job Description
Essential Duties and Responsibilities
To assure that the Artemis Plastics documentation is maintained according to our policies and procedures to support our Quality Management System (QMS).
Primary Functions
· Assist in developing policies, procedures, validations, product specifications, forms and templated in accordance with our QMS
· Assist in developing and maintain validation activities and related documentation
· Maintain Controlled Logs (such as CAPA, DCR, NCR, Calibration and related activities) and “working files” and FINAL approved version in their respective file locations
· Assist QA Manager in the process of updating documents (which involves requesting input from people at all levels and holding them accountable for prompt replies), as well as comfortability working autonomously. This includes leading the 3-year Document Review process to ensure documents have an expiration date and are reviewed and updated periodically.
· Assist with training and/or train end-users on the respective document change(s) that were made. Assist with loading training into the Training Database
· Maintain documents/data management system to capture all requirements, maintain the files, assure quality, control revisions and final versions of all documents.
· Assist with data collection, preparation, and maintenance of the records for Management Review Meetings, Internal and External Audits, Approved Supplier List, and other such documents and activities.
· Identify ways to streamline and/or enhance the efficiency of the document control process
· Assist with system automation
· Perform other duties as assigned
Secondary Functions
· Advise Quality Assurance Manager on finding that pertain to quality
· 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
Minimum Qualifications (Knowledge, Skills, and Abilities)
Education and/or Work Experience Requirements
· Ideal candidate for the Document Control Specialist position would be well versed in using a Quality Management System and related software (QMS and/or SAP)