Temp/Contract Document Control Specialist jobs in United States
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Caribou Biosciences · 18 hours ago

Temp/Contract Document Control Specialist

Caribou Biosciences is a biotechnology company seeking a Contract Document Control Specialist responsible for managing GxP-controlled documentation in compliance with regulatory requirements. The role involves supporting document lifecycle management and ensuring documentation integrity and audit readiness in a fast-paced environment.

BiotechnologyHealth CareOncologyTherapeutics

Responsibilities

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
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
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
Support cross-functional teams by coordinating document collaboration and ensuring consistent documentation standards
Contribute to audit readiness activities and respond to documentation-related inquiries

Qualification

GxP document controlVeeva EDMSGMP-regulated environment21 CFR Part 11PC proficiencyOrganizational skillsCommunication skills

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

Company

Caribou Biosciences

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Caribou Biosciences is a biotechnology company that develops CRISPR technologies and allogenic cell therapies for oncology.

Funding

Current Stage
Public Company
Total Funding
$317.7M
Key Investors
PfizerAnterra CapitalGenoa Ventures
2023-07-13Post Ipo Equity· $125M
2023-06-29Post Ipo Equity· $25M
2021-07-23IPO

Leadership Team

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Rachel E. Haurwitz
President and CEO
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J
James Berger
Co-founder
Company data provided by crunchbase