Temp/Contract Document Control Specialist

<p><strong>Position Summary</strong></p> <p>The contract Document Control Specialist is responsible for managing and maintaining GxP-controlled documentation in compliance with regulatory requirements and internal quality systems. This role supports document lifecycle management and electronic document systems in a fast-paced biotechnology environment. The position plays a critical role in ensuring documentation integrity, audit readiness, and continuous quality improvement across the organization.</p> <p>This contract role is a 6-month assignment hybrid role. The selected candidate is expected to work on-site at Caribou’s headquarters in Berkeley, CA at least 2 days per week. The pay range is $44.00 - $47.00 per hour.</p> <p><strong>Responsibilities</strong></p> <p><strong>Core Responsibilities – GxP Document Control & Compliance</strong></p> <ul> <li>As directed, manage GxP-controlled documents, including but not limited to SOPs, Process Records, Work Instructions, Forms, Templates, Policies, Batch Records, and Test Records.</li> <li>As directed, manage document collaboration, formatting, numbering, issuance, revision, and archival in accordance with established procedures.</li> <li>Process document change control requests through the Document Change Control (DCC) process, ensuring timely and compliant execution.</li> <li>As directed, track and manage periodic document reviews to ensure documents remain current and compliant.</li> <li>All other duties as assigned.</li> </ul> <p>Electronic Document Management & Systems</p> <ul> <li>Administer and maintain the Veeva Electronic Document Management System (EDMS) to support paperless document control.</li> <li>Proficient in Veeva quality docs and systems.</li> <li>Route documents for review and approval using DocuSign, including proper placement of signature fields and ensuring compliance with 21 CFR Part 11 electronic signature requirements.</li> <li>As directed, archive controlled documents in SharePoint and Veeva in accordance with record retention policies.</li> </ul> <p><strong>Secondary Responsibilities</strong></p> <ul> <li>Support training-related activities in Veeva, including tracking and updating training assignments and curricula.</li> <li>Assist with preparation, tracking, and presentation of document control and training-related KPIs.</li> <li>Provide document control or system-related training to staff as needed.</li> </ul> <p>Collaboration & Support</p> <ul> <li>Support cross-functional teams by coordinating document collaboration and ensuring consistent documentation standards.</li> <li>Contribute to audit readiness activities and respond to documentation-related inquires</li> </ul> <p><strong>Qualifications</strong></p> <p>Required</p> <ul> <li>Minimum of 2 years of experience in GxP document control within a pharmaceutical or biotechnology company.</li> <li>At least 2 years of hands-on experience managing documentation within the Veeva EDMS platform.</li> <li>Minimum of 2 years of experience working in a GMP-regulated environment.</li> <li>Strong organizational, prioritization, and planning skills, with the ability to manage multiple tasks in a fast-paced, team-oriented environment.</li> <li>Strong verbal and written communication skills.</li> <li>Proficient in working on a PC machine.</li> </ul> <p>Preferred</p> <ul> <li>Experience supporting training administration in Veeva or similar LMS platforms.</li> <li>Familiarity with preparing or presenting document control or training metrics/KPIs.</li> <li>Experience delivering training or system overviews to cross-functional teams.</li> <li>Familiarity with 21 CFR Part 11 requirements.</li> </ul> <p>This position is for a temporary or contract employee who will not be directly employed by Caribou Biosciences. Instead, the individual will be an employee of a third-party staffing firm and their work activities will be managed by the Caribou team. As a temporary/contract employee, you will collaborate closely with Caribou’s internal teams and contribute to our mission while reporting and getting supported by the staffing firm.</p>