GMP Document Control & Compliance Lead

Lancesoft; Boulder (CO); On-site; USD 55,000 - 90,000; Full time

Job summary

LanceSoft in Boulder, CO is seeking a Detail-Oriented Documentation Control Specialist to maintain all client documentation, ensure archival compliance, and support GMP production activities.

You will train personnel on the Training and Document Management System (TMS), manage labeling materials, support regulatory inspections, and collaborate with cross-functional teams to improve document processes.

Qualifications

• High school diploma or equivalent required.
• Experience in GMP production environment.
• Proficient with Microsoft Word, Excel, Access and Internet.
• Strong communication, written and verbal skills.
• Experience using Training and Document Management System (TMS).
• Ability to manage multiple projects and deadlines.
• Knowledge of GMP and ICH regulations for APIs and drug products.

Responsibilities

• Maintain all document files and assist in offsite archival.
• Manage controlled docs including logbooks, forms, batch records, and protocols.
• Handle document lifecycle using the Training and Document Management System (TMS).
• Plan and execute tasks to prepare and manage docs per procedures and regulations.
• Provide training to client personnel on TMS and related processes.
• Generate, review, and approve labeling materials.
• Represent Document Control in meetings, client interactions, and regulatory inspections.
• Support other projects or tasks delegated by the Document Control Supervisor.
• Evaluate processes, identify efficiencies, and drive change.

Skills

MS Word

MS Excel

MS Access

Internet proficiency

GMP experience

TMS knowledge

Effective communication

Project management

Education

High school diploma or equivalent

Tools

TMS system

Job description

LanceSoft in Boulder, CO is seeking a Detail-Oriented Documentation Control Specialist to maintain all client documentation, ensure archival compliance, and support GMP production activities.

You will train personnel on the Training and Document Management System (TMS), manage labeling materials, support regulatory inspections, and collaborate with cross-functional teams to improve document processes.