Temporary Document Control Associate I - TriLink BioTechnologies

Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our document control team as a Temporary Document Control Associate I. As a Temporary Document Control Associate I, you will play a critical part in ensuring the integrity and compliance of our document management processes within the Quality Management System (QMS). You will manage the lifecycle of key operational documents, including Standard Operating Procedures (SOPs), by coordinating their issuance, revisions, reviews, and approvals. Your attention to detail and organizational skills will directly contribute to maintaining the highest standards of quality and compliance, making you a key contributor to the success of our operations.

How you will make an impact: 

• Manage Document Control Processes: Assign and issue document change order numbers, expertly route and track new and revised documents through the approval process, ensuring that all documentation adheres to stringent change control procedures. Maintain an organized system for filing controlled and QA-provided documents to support quality assurance efforts.
• Ensure Document Accuracy and Compliance: Conduct thorough reviews of documents for completeness, ensuring they align with company formatting guidelines and contain the necessary approvals, contributing to the seamless execution of company procedures.
• Drive Timely Document Completion: Proactively monitor the status of in-process document changes to ensure timely updates and approvals, maintaining efficient workflows and minimizing project delays.
• Organize GMP/Research Filing Systems: Create and maintain robust and efficient filing systems for both electronic and paper-based GMP and research documents, facilitating quick retrieval and effective storage.
• Support and Enhance Quality Systems: Play a key role in the establishment, maintenance, and continuous improvement of quality systems, ensuring processes remain compliant and efficient while adapting to evolving industry standards.
• Champion Continuous Improvement Initiatives: Facilitate and contribute to ongoing quality system improvement efforts, identifying and implementing process enhancements that drive operational excellence.
• Assist in Quality Audits: Actively support quality audits, including document preparation and retrieval, ensuring audit readiness and contributing to successful audit outcomes.
• Maintain Quality Metrics: Regularly update and manage quality metrics, providing critical data to support decision-making and tracking continuous improvement goals.
• Provide Critical Support: Offer flexibility by supporting quality operations during after-hours and weekends when needed, ensuring the continuity of essential quality functions.
• Adapt to Dynamic Needs: Perform additional functions and duties as required, demonstrating versatility and a proactive approach to meeting the evolving needs of the organization.

 The skills and experience that you will bring:

• BS Degree in scientific area preferred. 
• Minimum of 1-2 years hands-on experience with document control management, preferably in a life science industry  
• Experience with ISO 9001, ISO 13485,  21CFR820, 21CFR 211, or other regulated industry a plus. 
• Experience with MasterControl or other document management system a plus but not required. 
• Demonstrated ability to work independently and as part of a team  
• Good writing skills, high degree of organization and excellent attention to detail. 
• Good computer skills with working knowledge of MS office suite and Adobe Acrobat. 
• Must be able to support after hours and weekend as needed. 
• Self motivated and able to organize and prioritize multiple tasks.  

The anticipated salary range for this position is $26.35 - $30.00 per hour. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.