Document Control Coordinator

Job Title

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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.