This position reports to the Technical Director. The Regulatory Compliance Associate is responsible for ensuring that products manufactured and/or sold by our client are in regulatory compliance with local, state and federal regulations in the U.S. and that products sold outside the United States conform to the applicable regulations in the country or region where they are sold.
- For products sold in the United States, ensure that our client's products only contain raw materials that are not prohibited in any state or under federal regulation. If a product contains a restricted material, ensure that its use meets the guidelines that have been established.
- Ensure that the operational aspects of our client comply with FDA Guidelines for Cosmetic manufacture by reviewing, adding and modifying SOP’s. Maintain the quality manual.
- For products sold in the United States, maintain documentation of the WERCS review process for retailers, submit new products to WERCS for evaluation and send WERCS evaluations to new Retailers as appropriate.
- For products sold in the United States, complete additional studies as required by states such as the California VOC study.
- Coordinate with ICMAD in order keep our client current on cosmetic issues. Complete CIR surveys as requested.
- For products sold outside the United States, ensure the products are properly registered in the country of sale by submitting all documents required for product registration in the country. Keep copies of all documents submitted.
- For products sold in the EU, work with our client's responsible person (Biorius) to ensure that complete portfolios are created and maintained on all products sold to EU countries.
- Develop documentation to support product claims. Maintain our client’s database of formulas, raw material information, Stability and Preservative Efficacy Tests.
- For products sold in the EU, monitor REACH compliance and determine on a yearly basis, the amount of raw material entering the EU under the REACH program. Ensure REACH monitored items are purchased as REACH compliant materials and have a REACH compliance certificate on file.
- Quality Audit – Conduct periodic audits to document Regulatory compliance.
- For all products generate and maintain GHS compliant Safety Data Sheets files.
- For all products, generate and maintain accurate ingredient statements based on current INCI nomenclature in Laboratory and Kallik label software databases.
- Create and maintain an equipment calibration program.
- Other duties as assigned by the Technical Director.
- Maintain a safe and satisfactory work area as determined by OSHA and company guidelines and procedures.
- Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It may not involve solving the problem, only recognizing there is a problem.
- Selective Attention - The ability to concentrate on a task over a period of time without being distracted.
- Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
- Language Skills - Ability to read and interpret documents and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Mathematical Skills - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Understand the concept of percent. Have knowledge of statistical concepts.
- Reasoning Ability - Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
- Ability to effectively utilize computer programs such as Microsoft Excel, Microsoft Word, Adobe Acrobat, Microsoft Dynamics and Vicinity Manufacturing.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in an appropriate discipline or equivalent experience.
- 5 years of regulatory or quality assurance experience.
WORK ENVIRONMENT AND PHYSICAL DEMANDS:
- Generally an office environment however occasional work in a non-climate controlled warehouse/manufacturing environment with machine and production line noise.
- Ability to stand, walk, sit, squat, bend, and climb.
- Ability to lift and carry up to 50 pounds