Document Control Specialist

VOLT • BOULDER, CO

13d

About The Position

Volt is hiring a Document Control Specialist in Boulder, Colorado. The role maintains and archives document files, manages controlled documentation and its lifecycle through the site Training and Document Management System (TMS), and ensures documents are prepared on time and handled in accordance with procedures and applicable regulations. The specialist also generates, reviews, and approves labeling materials; represents Document Control in internal meetings, customer interactions, and regulatory inspections; and supports additional projects assigned by the Document Control Supervisor. This is described as a full-time contract opportunity.

Requirements

• High school diploma or equivalent.
• Skill using computer software and hardware applications, including Microsoft Word, Access, and Excel, and the Internet.
• Prior experience and/or training working in a GMP production environment.
• Ability to use, maintain, and train others in the TMS system.
• Ability to effectively present information and respond to questions from coworkers, managers, contractors, and customers.
• Knowledge of GMP guidelines and International Conference on Harmonisation (ICH) regulations pertaining to production of APIs and drug products.

Responsibilities

• Maintain document files and assist with archiving documents at the offsite storage location.
• Issue and reconcile controlled documentation, including logbooks, notebooks, controlled forms, batch records, and protocols.
• Handle the document lifecycle using the site Training and Document Management System (TMS).
• Plan and execute multiple tasks to ensure controlled documents are prepared on time, managed according to procedures, and aligned with applicable regulations.
• Generate, review, and approve labeling materials.
• Represent Document Control in internal meetings, customer interactions, and regulatory inspections.
• Support other projects or tasks delegated by the Document Control Supervisor.
• Evaluate processes, identify efficiencies, and motivate change.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Term life insurance
• Short-term disability
• AD&D
• 401(k)
• Sick time
• Other paid leaves as required by law
• Employee Assistance Program (EAP)

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED