Document Control Coordinator

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

Responsibilities

• Enter Job Description... Maintains all document files as related to client NASD and assists in the archival of documents at the offsite storage location
• Issues and reconciles controlled documentation including logbooks, notebooks, controlled forms, batch records, and protocols
• Handles the document lifecycle using the site Training and Document Management System (TMS)
• Plans and executes multiple tasks to ensure controlled documents are prepared on time, managed per procedures, and align with applicable regulations
• Provides training to client personnel on TMS and related processes
• Generates, reviews, and approves labeling materials
• Represents Document Control (DC) in internal meetings, customer interactions, and Regulatory inspections
• Provides support on various other projects or tasks delegated by Document Control Supervisor
• Possesses the ability to evaluate processes, identify efficiencies, and motivate change

Job Qualifications

• High school Diploma or equivalent
• Skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and the Internet
• Prior experience and/or training working in a GMP production environment
• Possesses skills in effective communication, written, and verbal
• Ability to use, maintain, and train in the TMS system
• Ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers
• Responsible for managing various projects
• Knowledge of GMP guidelines as well as international conference on harmonization (ICH) regulations pertaining to the production of APIs and drug products

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.