As our Irvine, California-based Documentation Specialist for Nutrition Products, your mission is to ensure the company documentation control system is in compliance with corporate policies, FDA cGMP and other regulations by controlling documents, including the review, change, control, distribution, retention and archiving of relevant Product Development documentations. Your background and experience should include:
Collecting and maintaining documentation for quality control and product dossiers.
Assisting with outline and development of organizational SOPs.
Ensuring the company documentation control system is in compliance with corporate policies, FDA cGMP and other regulations around foods/dietary supplements by control of documents, including the review, change, control, distribution, retention and archiving of relevant R&D documentations.
Developing and maintaining a comprehensive filing system and computer database for all documents to be retained in the document control center
Managing the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner.
Acting to support Change Control Board in organization and tracking of all outlined and required/impacted changes within the Nutrition category.
Collecting and maintaining files of the latest revision level documentation necessary to define product configuration and control manufacturing processes.
Timely distribution of latest revision level documentation to all appropriate users and ensuring that obsolete documentation is removed from distribution.
Performing clerical typing duties to generate documents as necessary
Technical writing and analysis skills; high accuracy on document preparation and review
Proficient computer skills (Excel, Word, adaptable to government website and internal software programs)
Detail oriented, highly organized, and able to work with intricate spreadsheets and data/document collection
High level observation skills, quick learner
2 or more years of experience in the food product or dietary supplement industry
Knowledge of/experience in quality, product development or regulatory areas of dietary supplement industry
Basic understanding of nutrition supplements and food ingredients
Bachelor’s degree in Food or Physical Sciences
Ithos and Oracle knowledge a plus, but not required
Knowledge of nutrition regulations in US, EU and/or Canada is ideal
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