
10/24/17- Documentation Administrator
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Accentuate Staffing is currently recruiting for a Documentation Administrator to join an established company in the Apex area. This position is responsible for handling complaints received from customers and communicating with suppliers and manufacturers.
Responsibilities:
• Responsible for the maintenance of Quality Management System (QMS) documentation.
• Responsible for maintaining the complaint log and processing complaints in accordance with the Customer Complaints procedure and serving as delegate for the Quality Manager for this procedure.
• Responsible for assuring all controlled records are stored, maintained and retrievable in accordance with quality system requirements
• Responsible for retrieving and logging any documentation requested by the Management Representative during an on-site customer or FDA audit in accordance with the QMS.
• Prepare and distribute Weekly Complaints Report to Company staff.
• Respond to customer inquiries/questionnaires for QA/RA information and prepare all requested forms/documents for QA/RA review & sign-off.
• Responsible for timely processing of customer feedback including monitoring of administration activities and communication with customers for resolution.
• Process customer complaints on a timely basis, coordinating with product managers and suppliers as needed.
• Process more complex customer inquiries regarding QA/RA i.e. CFGs, documents/information needed from suppliers etc.
• Track quality training requirements. Set up and coordinate training meetings.
• File and retrieve organizational documents, records and reports.
• Prepare summaries for regularly scheduled customer complaint review meetings.
• Maintain a schedule of reoccurring events defined by the Quality Management System and additional events added by the Quality Manager.
• Support Quality Training during new hire orientation by preparing Training Record Forms as required for employee training, and support the maintenance of Quality Training records.
Requirements:
• Bachelor’s degree, including course work related to: problem solving, information structures, knowledge schemas, data management, and search functions.
• A minimum of two to three years’ experience working in an office setting (i.e. intern in law office, library research desk, hospital, physician’s office, engineering department, quality department).
• Above average customer facing written and oral communication skills.
• Proficient in Microsoft Office Applications (Word, Excel, PowerPoint, Outlook); experience with Visual Processing software a plus; experience with SAP and SharePoint preferred but not required.
• Understanding of medical terminology, US FDA regulations, ISO standards, and/or Health Canada regulations.
• International business experience.
• Ability to communicate in a foreign language (Chinese, Japanese, Indian, Malaysian).