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Document Control Coordinator
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 Boulder, CO. The shift for this position will be Monday -- Friday from 8:00 am -- 4:30 pm.
Responsibilities and duties include:
* Handles the document lifecycle utilizing 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 handled per procedures and applicable regulations. * Provides training to Agilent personnel on TMS. Acts as liaison with TMS vendor for training on new modules to assist in troubleshooting TMS. * Generates, reviews, and approves labeling materials for accuracy. * 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. * Is able to evaluate processes, identify efficiencies, and lead change.
* 3+ years related experience. * 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. * Possesses skills in effective communication, written, and verbal. Possesses the ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers. * Has skills handling various projects; can use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish time-sensitive goals and objectives. * Knowledge of GMP guidelines as well as international conference on harmonization (ICH) regulations pertaining to the production of APIs and drug products. * Able to lead teams and work cross-functionally to meet site objectives.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
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