Document Specialist - Catalyst Nutraceuticals

Product Development Document Specialist Job Description

• Position Reports to: Document Specialist Manager
• Position Summary: The Product Development Document Specialist is responsible for reviewing and maintaining technical documentation and information pertaining to all products and ingredients. This role will act as a liaison between Development, Quality, and external customers to produce compliant technical documentation within a rapidly evolving regulatory environment. This individual will understand and apply regulatory concepts through technical information and regulatory references to substantiate claims for new and existing products, supporting customer compliance and research requests
• Essential job Duties/responsibilities:
• Collects and enters technical documents into the appropriate software to develop Finished Product Specifications
• Manages the submission of Finished Product Specifications and Labels for customer sign-offs and subsequent internal communications
• Responsible for initiating deviations and change controls as designated by matrix of responsibility
• Preparation and management of technical and other standard regulatory documents (Technical Data Sheets, etc.) before submission to internal and external customers
• Review customer artwork and labels for compliance, as needed
• Coordinates support documentation for product claims, regulatory filings, and certification submissions as needed

• Collaborates with R&D, Quality, Operations, Procurement, Marketing and External Suppliers to support the needs across the business

• Execute special projects to ensure compliance with evolving regulatory statutes
• Provides technical support to various internal departments while supporting the development and regulatory platform

• Provide insights into ingredient documentation, finished product specifications, nutritional facts/supplement facts, product development, and FDA compliance regulations (21 CFR 101, 111, etc.)
• Manages internal file system for ingredient, product, and technical R&D documents.
• Educational/Experience Requirements
• 4 year college/university degree in Chemistry, Food Science or other relevant subject, and 1-3 years’ related work experience or 3-4 years solid dose development experience preferred.
• Able to use scientific method.
• Able to function in a laboratory and production setting.
• Required Knowledge skills and abilities
  • Must be able to understand, speak, read and write in English in order to perform the essential functions of the job as they relate to comprehension of laws, regulations, standards, documents and other internal and external communications.
  • Able to complete accurate and precise work in a timely manner.
  • Possess excellent written and verbal communication skills.
  • Able to work without direction in “Office” programs especially document creation, spreadsheets and email.
  • Ability to use company ERP and other related software programs with efficiency
  • Familiar with and have experience calculating Nutritional values of formulas
  • Familiar with product labeling regulations and guidelines
• Physical Requirements
  • Must occasionally lift up to 50lbs
  • May be required to wear personal protective equipment.
• Work environment
  • Regularly subject to normal office or laboratory environment
  • Occasionally subject to normal warehouse and production environment
  • Occasionally subject to high noise levels where hearing protection is required, and all personnel protective equipment is required.
  • Occasionally subject to atmospheric conditions, such as fumes, odors, powders, dust and other particles