Document Control Specialist

The Specialist ensures product compliance with corporate Arbonne polices and complete documentation control to meet the standards of FDA, cGMP and other global regulations including review, change-control, distribution, and archiving of relevant Product Development and Quality Controlled documents. This role is responsible for safety, efficacy, and clinical testing reporting, and the liaison between Third-Party Manufacturers, Senior Product Managers, Regulatory, and Marketing departments.

What you’ll be doing:

• Review product Certificates of Analysis for completeness and compliance to Arbonne internal Finished Good Specifications.
• Responsible for product releases from distribution Warehouse
• Assist in the review of product deviations
• Request the required product testing document and justifications from Third-Party Manufacturers in collaboration with the Quality Manager.
• Participate in the development, revision, and implementation of documented procedures and work closely with members of cross-functional teams throughout the organization.
• Coordinate and manage the implementation of product changes both internally and with Third-Party Manufacturers through the management of formula, finished good spec, and label updates.
• Assign, create, and track the development, approval, and storage of all controlled documents (Formulas, FGS, Labels, Packaging specs, etc.).
• Extract, re-format, route Ithos derived formulas.
• Create and manage product finished good specifications, in collaboration with the Quality Manager.
• Track and maintain all product configuration records in coordination with Document Control.
• Ensure documents submitted to and received from Third-Party Manufacturers are reviewed and approved promptly in accordance with internal document control processes.
• Ensure orderly storage and organization of all documentation in compliance with internal procedures and current Good Manufacturing Practice (cGMP) regulations in coordination with Document Control along with storage under corporate policies.
• Manage and ensure stability requirements are met in terms of form, fit, and function, in collaboration with Quality Manager.
• Participates in monthly product stability review meetings, scheduled by R&D.
• Coordinate the submission of samples and/or reporting back stability testing results with the TPM and/or external laboratory.
• Create/review stability testing protocols and monitor costs, in coordination with the Quality Manager.
• Implement processes to ensure effective documentation control and management of international product dossiers and compliance files in coordination with Document Control.
• Partner with Regulatory and R&D to monitor and update the Heavy Metal matrix grid and determine safe harbor levels for each heavy metal.
• Collaborate and lead additional assigned projects, as needed.
• Each employee is responsible for raising awareness of our commitment to Corporate Social Responsibility and should actively participate in activities and initiatives which are designed to have a positive impact on the environment and local communities.
• As an employee of a purpose-driven company, you are required to establish a goal relative to social and environmental impact.

What you need:

• Bachelor’s degree in chemistry, Food Science, or other similar science preferred
• Two or more years of experience in Manufacturing or related industry experience
• Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, etc.)
• Good communication skills (Written and Verbal)
• Experience writing and reporting on project statuses either written or verbal.
• Experience facilitating project development and communications with Third-Party affiliates.
• Experience collaborating closely with cross-functional teams.
• Experience using Oracle, Agile, Ithos, or similar databases a plus
• Experience in document control, change control procedures, product testing, and CAPAs
• Knowledge of industry-standard testing practices
• Commitment to model and live out our Core Values (Accountability, Community, Innovation, and Courage) and a positive mindset are critical for success and should reflect in everything you do.

The salary range is $65,000-$70,000/yr.

Arbonne International is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sexual orientation, national origin/ancestry, age, sexual orientation, gender identity, gender expression, military/veteran status, marital status, disability status or any other basis prohibited by law. At Arbonne International it’s about each person bringing passion and skills to a dynamic and inclusive workplace!