Document Control System Specialist

Document Control System Specialist Become part of a team that champions wellness worldwide. CAPTEK Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world's most successful brands. The Document Control System Specialist is responsible for the comprehensive administration, optimization, and support of the company's MasterControl electronic documentation management system (EDMS), ensuring seamless integration of document workflows in compliance with GMP and regulatory standards. This role encompasses training, troubleshooting, and technical liaison for MasterControl, while also assisting with the full lifecycle of controlled documents critical to GMP operations. The Specialist ensures the accuracy, accessibility, and integrity of Standard Operating Procedures (SOPs), Master Manufacturing Records (MMRs), Production Batch Records (PBRs), test data sheets, Safety Data Sheets (SDS/MSDS), controlled forms, and other regulated documentation, supporting quality assurance and operational excellence across departments. Essential Duties and Responsibilities: Proactively monitors and maintains MasterControl performance, executing system audits, identifying potential issues, and performing routine maintenance for optimal system uptime and functionality. Designs, configures, and implements new workflows within MasterControl, collaborating with departmental managers to define user needs, establish timelines, and ensure effective rollout and training. Serves as the primary technical liaison with MasterControl support for complex issue resolution, system upgrades, and enhancement requests. Oversees user access, including creation, modification, deactivation of user accounts, role-based access control, and maintaining user audit trails for compliance tracking. Delivers comprehensive technical support and training to end-users, developing user guides and SOPs, and conducting ongoing training sessions to enhance system proficiency and compliance awareness. Develops and trains stakeholders on data extraction tools, enabling accurate and timely generation of weekly, monthly, and annual compliance and operational reports. Standardizes initiatives for Master Manufacturing Records (MMRs) within MasterControl, ensuring consistency, regulatory alignment, and ease of use across production sites. Creates, reviews, revise, and distribute controlled documents, ensuring adherence to formatting standards, document lifecycle protocols, and timely communication with plant and quality management. Assigns and tracks Document Change Requests (DCRs), ensuring control numbers are issued systematically, and all DCRs are reviewed for accuracy, completeness, and compliance with SOPs. Formats and validates documents submitted for control, ensuring readability, regulatory compliance, and conformance to internal documentation standards. Coordinates with QA and Production teams for the issuance and reconciliation of batch records and verify in-process parameters via RedZone to support real-time production tracking. Audits document control processes and systems, ensuring availability, traceability, and regulatory compliance of all documentation accessible to site personnel. Supports internal and external audits by ensuring timely retrieval and presentation of controlled documents, maintaining a high state of audit readiness. Participates in cross-functional projects aimed at continuous improvement of documentation practices, quality systems, and digital transformation initiatives. Performs other duties as assigned by QA Management, contributing to the broader goals of Quality Assurance and operational compliance. Qualifications/Education/Experience: AA degree preferred Minimum of 3 years' relevant work experience in document control and/or equivalent combination of education and experience. Strong verbal and written communication Excellent organizational skills/attention to detail / ability to work effectively in a fast-paced environment. Strong proficiency in using Microsoft Word, Excel, Outlook, and PowerPoint. Ability to set priorities, be flexible, multi-task and meet deadlines. Ability to manage time and work independently with minimal supervision. Strong working knowledge of quality systems; MasterControl, Quality Collaboration By Design (QCBD) and Syspro Working knowledge of current Good Manufacturing Practices (cGMP) and Food and Drug Administration (FDA) regulations as it pertains to document control, preferred. #J-18808-Ljbffr