Description:
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
We are currently hiring a Document Control Coordinator to join our team in Frederick, CO.
Responsibilities:
- Handles the document lifecycle using the site Training and Document Management System (TMS).
- Maintains all document files as related to Agilent 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.
- Plans and executes multiple tasks to ensure controlled documents are prepared on time, managed per procedures, and align with applicable regulations.
- Provides training to Agilent 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.
Shift: 10:00 AM - 6:30 PM MT
Qualifications
- High school Diploma or equivalent
- Typically at least 1-3 years of relevant experience for entry to this level
- Prior experience and/or training working in a GMP production environment
- Skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and the Internet. Ability to use, maintain, and train in the TMS system. Typically at least 1-3 years of relevant experience for entry to this level
- Possesses skills in effective communication, written, and verbal.
- Ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers.
- Responsible for managing various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives.
- Knowledge of GMP guidelines as well as international conference on harmonization (ICH) regulations pertaining to the production of APIs and drug products.
- Possesses the ability to lead teams and work cross-functionally to meet site objectives.