Temp/Contract Document Control Specialist at Caribou Biosciences, Inc.

, , -

Full Time

Start Date

Immediate

Expiry Date

24 Apr, 26

Salary

47.0

Posted On

24 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GxP Document Control, Compliance, Document Management, Veeva EDMS, Change Control, Audit Readiness, Training Administration, Collaboration, Organizational Skills, Communication Skills, Document Formatting, Record Retention, Quality Improvement, Team Coordination, 21 CFR Part 11, PC Proficiency

Industry

Biotechnology Research

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.

Responsibilities

The Document Control Specialist manages GxP-controlled documents and ensures compliance with regulatory requirements. This role also supports document lifecycle management and electronic document systems.