Job Description
Position Summary
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.
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.
Responsibilities
Core Responsibilities – GxP Document Control & Compliance
- As directed, manage GxP-controlled documents, including but not limited to SOPs, Process Records, Work Instructions, Forms, Templates, Policies, Batch Records, and Test Records.
- As directed, manage document collaboration, formatting, numbering, issuance, revision, and archival in accordance with established procedures.
- Process document change control requests through the Document Change Control (DCC) process, ensuring timely and compliant execution.
- As directed, track and manage periodic document reviews to ensure documents remain current and compliant.
- All other duties as assigned.
Electronic Document Management & Systems
- Administer and maintain the Veeva Electronic Document Management System (EDMS) to support paperless document control.
- Proficient in Veeva quality docs and systems.
- 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.
- As directed, archive controlled documents in SharePoint and Veeva in accordance with record retention policies.
Secondary Responsibilities
- Support training-related activities in Veeva, including tracking and updating training assignments and curricula.
- Assist with preparation, tracking, and presentation of document control and training-related KPIs.
- Provide document control or system-related training to staff as needed.
Collaboration & Support
- Support cross-functional teams by coordinating document collaboration and ensuring consistent documentation standards.
- Contribute to audit readiness activities and respond to documentation-related inquires
Qualifications
Required
- Minimum of 2 years of experience in GxP document control within a pharmaceutical or biotechnology company.
- At least 2 years of hands-on experience managing documentation within the Veeva EDMS platform.
- Minimum of 2 years of experience working in a GMP-regulated environment.
- Strong organizational, prioritization, and planning skills, with the ability to manage multiple tasks in a fast-paced, team-oriented environment.
- Strong verbal and written communication skills.
- Proficient in working on a PC machine.
Preferred
- Experience supporting training administration in Veeva or similar LMS platforms.
- Familiarity with preparing or presenting document control or training metrics/KPIs.
- Experience delivering training or system overviews to cross-functional teams.
- Familiarity with 21 CFR Part 11 requirements.
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.
