Document Control Specialist

VOLT • BOULDER, CO

1d

About The Position

Volt is hiring a Document Control Specialist in Boulder, Colorado. The role maintains and archives document files, issues and reconciles controlled documentation, and manages document lifecycles through the site Training and Document Management System (TMS). The specialist plans and executes tasks to prepare and manage controlled documents on time, in accordance with procedures and applicable regulations. The position also generates, reviews, and approves labeling materials; represents Document Control in internal meetings, customer interactions, and regulatory inspections; and supports other projects or tasks delegated by the Document Control Supervisor. The specialist is expected to evaluate processes, identify efficiencies, and motivate change.

This is a full-time contract opportunity. The stated pay range is $24.82 to $26.82 per hour. The offered rate may depend on factors including education, work experience, work location, job duties, and certifications.

Requirements

• High school diploma or equivalent.
• Skill in 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 co-workers, managers, contractors, and customers.
• Knowledge of GMP guidelines and International Council for Harmonisation (ICH) regulations pertaining to production of APIs and drug products.

Responsibilities

• Maintain related document files and assist with archiving documents at an 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 prepare controlled documents on time and manage them according to procedures and 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, dental, and vision benefits, subject to eligibility.
• Term life insurance, short-term disability, and AD&D, subject to eligibility.
• 401(k), subject to eligibility.
• Sick time and other types of paid leave as required by law.
• Employee Assistance Program (EAP).

What This Job Offers

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