Manages Regulatory, Validation and OTC Stability Programs.
· Manages Validation Coordinator
o Provides support for Validation and OTC Stability Programs
· Reviews and approves Validation Documentation (reports, worksheets and summaries)
o Includes IQ, OQ and PQ documentation
· Assists with customer needs on the Validation/Stability programs
o Includes communicating statuses and test results
· Approves design of new Validation Projects
· Responsible for creating and updating Validation Master Plans
· Assists with FDA and customer audits
o Supports requests and concerns as well as requested documentation
· Provides Regulatory guidance and advice to R&D and other internal partners.
· Creates QQ and Ingredient Listing files for Cosmetic and OTC products.
· Manages client needs with raw material suppliers to ensure client/legal compliance.
· Provides support on day-to-day regulatory issues, new initiatives and developments.
· Responsible for authoring department SOPs.
· Responsible for creating and managing finished good SDS files.
· Responsible for managing customer’s international registration requirements.
· Provides weekly updates to VP in regards to regulatory and validation request/projects.
· Bachelor's Degree in Chemistry/Biology or related field from accredited college or university
· At least 5 years experience in Cosmetic/OTC Regulatory/Validation environment
· Experience in Manufacturing
· Experience in Management
· Ability to work in a fast paced environment
· Able to read, write and speak English
· Proficient in Microsoft Office applications
Job Type: Full-time
Salary: $60,000.00 to $100,000.00 /year
This Job Is Ideal for Someone Who Is: