Document Control Coordinator
Infinium Medical
Date: 1 week ago
City: Largo, FL
Contract type: Full time
Description
Document Control Coordinator (DCC) is responsible for managing company documents while also ensuring their accuracy, quality and integrity. The DCC helps the company adhere to record retention policies, safeguard information and retrieve data more effectively. Duties include, but not limited to:
Document Control Coordinator (DCC) is responsible for managing company documents while also ensuring their accuracy, quality and integrity. The DCC helps the company adhere to record retention policies, safeguard information and retrieve data more effectively. Duties include, but not limited to:
- Manage change control processes for SOPs, WI, Forms, protocols, technical reports, software, and other GMP documents;
- Perform document change control activities including routing, tracking, and expediting change control packages, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management;
- Coordinate the engineering change control and label change control processes;
- Organize and ensure a reliable archiving (filing) system of paper-based and electronic GMP documents and a timely retrieving process of such documents from the archive upon request;
- Provide both formal and informal training to coworkers on document control and document change processes;
- Enforce GMPs requirements and Quality Systems & Regulatory Compliance Department’s policies with regard to documentation, including formatting and Good Documentation Practices (GDPs);
- Assist in internal investigations and external audits by promptly retrieving GMP documents needed for the investigation or audit;
- Scan all quality records and maintain scanned document in an organized manner that is readily available;
- Maintain a state of document inspection readiness and provide support during regulatory and other audit-related activities;
- Prepare and issue production packets including: production travelers, functional test report, product labels;
- Issue and maintain product serial numbers;
- Promptly and accurately review production and QC records and identify product records that do not meet product release requirements;
- Print and issue Product labels upon final release of product;
- Maintain Document Control Database system;
- Ensure reviews, approvals, and training for documents are completed in a timely manner;
- Assist in retrieval of documents and completion of forms requested for device registration and approval;
- Perform other duties as assigned by the Director of Quality Assurance & Regulatory Affairs;
- 1+ years related experience in a cGMP environment
- Experience with quality systems with FDA regulations, cGMP, and/or ISO 13485 preferred
- Experience in the review of process batch and test records, deviations, and change controls
- Experience in performing routine internal and external audits
- Ability to clearly summarize and communicate compliance issues to staff
- Advanced proficiency in MS Word and Excel
- Comfortable learning and using
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