Document Control Coordinator
Agilent Technologies, Frederick, CO, Onsite
Quality Assurance ControlHigh School RequiredMid Level
About the role
Job 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 II to join our team in Frederick, CO.
Responsibilities:
- 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
- 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 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
Required:
- High school Diploma or equivalent
- Skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and the Internet
Desired:
- 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
About Agilent Technologies
Agilent customers are finding new ways to treat cancer, ensure food, water, air, and medicine quality and safety, discover new drug treatments, research infectious diseases, and create alternative energy solutions for a greener planet. From start to finish, we have them covered with our vast product solutions and services portfolio. Around the world, Agilent’s people bring innovations, technologies, and services to the forefront of science. Our teams design and manufacture a wide array of advanced analytical, research, and diagnostic solutions and tools for use inside and outside laboratories. Additionally, the unique expertise of Agilent’s CrossLab and technical teams provides valuable insight and support to our customers, helping them fully optimize their laboratories and resources to better focus on what's important: bringing great science to life. In fiscal 2022, Agilent Technologies generated revenue of (US) $6.85 billion.