Organovo
San Diego, CA
Feb 17, 2019
OrganovoAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disabilityCategory: QualityLocation: San Diego, CaliforniaWe are seeking a temporary Document Control Specialist I. This person will be assisting with the development, implementation, and maintenance of the Quality System for Organovo. His or her primary focus will be to track, manage, and archive Quality Controlled documents and Quality related records, including training records, forms, and batch records.Document Control Specialist I Responsibilities:Track employee training and product development processes to ensure that company quality standards are met.Manage all quality records and ensures that all document locations are organized and easy to find.Review routing, approval, and release of SOP's and all Quality Controlled documents.Review and document product labeling, advertising, and promotional documents.May be involved in disposition of raw materials.Other Duties as assigned.Document Control Specialist I Skills and Experience:BS in a life science area, such as Biology, Chemistry, Microbiology, Immunology, etc.1-3 years of practical experience in Quality Assurance activities and GMP / GLP standards as they relate to product development, manufacturing, and technology transfer.Ability to interpret and relate quality standards for implementation and review.Knowledge of basic document control principles.Ability to read, analyze, and interpret technical procedures and regulations.Ability to effectively present information and respond to questions from groups of managers, clients, and customers.Experienced with Word, Excel, and PowerPoint.Working knowledge of MS Project and document management systems a plus.Familiarity with GLP and GMP regulations.Familiarity with drug development.Ability to work collaboratively with multi-disciplinary groups in a fast-paced work environment.Effective oral and written communication skills.PI107806713