The Document Control Team is a key element of the Quality Assurance department and is responsible for the control, management and storage of all company quality records. As a member of the Document Control Team, this position provides support to departments by scanning and uploading quality records into the Enterprise Resource Planning (ERP) system, SAP. Under the direct supervision of department management, and in accordance with company record management procedures, carries out daily tasks and assigned projects; including, but not limited to, creating, tracking, monitoring, labeling, delivery, closure and storage of various quality records (e.g. device history, quality inspection/testing, validation, calibration, maintenance, etc.). Works collaboratively with department management and team members to ensure the Document Management module within SAP is maintained and in compliance with established procedures.

Key Accountabilities

• Provides the first point of contact for departments regarding the processing, scanning and uploading of various quality records into SAP’s Document Management module.
• Follows procedures to accurately and timely scan and archive quality records and perform activities to control and/or maintain accurate quality records uploaded into SAP.
• Ensures all work is completed in accordance with established SOPs and/or Work Instructions and under the direction of Supervisor.
• Ensures scanned quality records are filed and archived in accordance with established procedures to support timely retrieval from SAP and/or off-site storage location.
• Collaborates with other departments and teams as needed to facilitate document scanning/retrieval, as needed.
• Prepares quality records prior to scanning, reviews scanning packet information to ensure clear and legible documentation and supports theQuality Management System requirements during internal and external audits.
• Supports department management by coordinating the shipping and retrieval quality records from off-site storage location. Ensures documentation is controlled and returned to its appropriate storage location (i.e. box, etc.) in accordance with established procedures.
• Responds to specific requests by searching, locating, retrieving, and delivering records or information through established procedure and delivery systems in a timely manner.
• Assists in the resolution of document scanning/retrieval issues, while able to recognize high priority situations and take appropriate escalation actions, as needed, to ensure quality record compliance is maintained.
• Documents, tracks, and manages quality record scanning back-log in accordance with established Standard Operating Procedures (SOPs) and department operations.
• Maintains training requirements applicable to job role(s) and performance of associated activities in compliance with SOPs.
• Performs other duties and projects as assigned to meet company and department objectives.
• Complies with applicable SOPs, ISO, FDA and other applicable Quality System regulations, as well as applicable Environmental Heath & Safety, Human Resources, and all other regulatory and administrative policies.

Experience:

• 0 - 2+ years of work-related experience in document scanning or document administrative control experience required.
• FDA Medical Device industry background preferred.

Skills & Knowledge:

• Working knowledge of Microsoft Office suite, Adobe Acrobat, and experience with ERP document control software required, preferably SAP.
• Organization skills required, including ability to manage duties through time management, prioritizing workload and attention to detail.
• Able to communicate across various employee levels (i.e. floor level, mid and upper management) required.
• Proven ability to multi-task, follow procedures, work collaboratively on a team, excel under pressure, adapt in a fast-paced support role strongly preferred.