CATALYST NUTRACEUTICALS: is dedicated to manufacturing premium-quality dietary supplements that set the standard for excellence in the industry. We take pride in every product we produce and are committed to delivering exceptional quality, value, and innovation. Our success is built on strong partnerships with employees, customers, suppliers, and industry experts, allowing us to stay ahead of market trends while maintaining the highest standards of service, pricing, and product integrity. At Catalyst Nutraceuticals, quality isn't just a goal, it's the foundation of everything we do.
Position Reports to: Technical Documentation and Product Regulatory Manager
Position Summary: The Label Coordinator and Technical Documentation Specialist is responsible for reviewing and maintaining technical documentation and information pertaining to all products and ingredients, and for working directly with customers to review, revise, and approve label and packaging artwork. This role acts as a liaison between Development, Quality, external customers, and vendors to produce compliant technical documentation and packaging within a rapidly evolving regulatory environment. As a member of the product development team, this individual is critical to facilitating the Label Panel Review (LPR) process-managing customer artwork submissions, communicating findings and observations, and maintaining the latest approved artwork revisions and files. This individual will understand and apply regulatory concepts through technical information and regulatory references to substantiate product content claims for new and existing products, supporting customer compliance requests.
Essential job Duties/responsibilities:
- Manages the submission of Labels for customer sign-offs and subsequent internal communications
- Responsible for initiating label deviations and change controls as designated by matrix of responsibility
- Review customer artwork and labels for compliance
- Work directly with customers as the primary point of contact throughout the label and packaging artwork review and approval process, facilitating the Label Panel Review (LPR) from artwork receipt through final approval
- Log and track all customer artwork submissions in the Label Review Tracker and communicate LPR findings (mandatory changes required for FDA compliance) and observations (recommended improvements) back to the customer for revision or sign-off
- Manage version control of label and packaging artwork, maintaining the most current approved digital files in the approved label folder and re-validating artwork (e.g., confirming files older than six months remain valid) prior to reorder
- Coordinate artwork revisions and label transitions (soft and hard changes) with customers, accounting, and the packaging quarantine/destruction process to ensure only approved artwork is used in production
- Compare vendor printer's proofs against the last approved digital file for content and size accuracy prior to production approval
- 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 or 1-3 years' related work experience. Having both
education and experience preferred.
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 or have experience with supplement or nutrition facts panels.
- Strong customer-facing communication skills to manage external artwork reviews, approvals, and revisions professionally
- Highly organized with strong version control and document/file management practices for maintaining current artwork revisions
- Preferred: Familiar with label and packaging artwork review workflows, printer's proofs, and proofing against approved digital files
- Preferred: Familiar with product labeling regulations and guideline
Physical Requirements
Work environment
- Regularly subject to normal office or laboratory environment
Employment Eligibility Verification
- Must possess valid documentation to establish identity and U.S. employment eligibility.
Security Requirements
- Submission to, and ability to pass, a thorough pre-employment background check by Catalyst is a requirement of employment.
Catalyst is an Equal Opportunity Employer