Jillian Wilson

Experience

1. Regulatory and Document Control Specialist

   Prima Fleur Botanicals

   Aug 2016 — Present · San Francisco, CA, US

   REGULATORYCollect and coordinate information and prepare regulatory documentation forsubmission to regulatory agencies or to commercial partners, advise on thesubmission strategyTimely compile materials for license of specific documents or certificates, updates and registrationsMaintain regulatory files/database and chronologies in good order. Establish andmaintain system for tracking changes in documents submitted to agencies orpartnersReview labeling and labels for compliance with regulatory requirementsReview changes to existing products and SOPs to define the requirements forregulatory submissionsResponsible for timely registration of the facilityMaintain current knowledge of FDA and international regulation, guidance andstandards applicable to company productsActively participate in evaluation of regulatory compliance of document / product /process /test methods changesParticipate in research of regulatory issues and dissemination regulatory informationto Production, QA, QC and R&D departments and senior management as required. DOCUMENT CONTROL:Establishing a procedural framework for identifying, collecting, distributing and filing the controlled documents for the Program. This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools, such as scanning hardware, computer software, etc. Ensure the information and management control system is implemented in compliance with the ISO 22716; and is updated to reflect revisions to those standards. Ensure the all staff are provided with adequate training and support to enable them to successfully use the procedure. Proactively conduct “spot audits” and “over-the-shoulder-reviews” of staff to facilitate their understanding and enhance their compliance to Document Controls procedures.Provide Quality Assurance / Quality Control audits of the hard copy Document Control files and the electronic Document Control files.

Skills

• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Paychex
• Gmp
• Clinical Manufacturing
• U.s. Food and Drug Administration (Fda)
• Automotive Sales Training
• Marketing Event Planning
• Expense Reports
• Data Entry
• Microsoft Publisher
• Customer Service
• Employee Training
• Music Production
• Leadership
• Social Media Marketing
• Songwriting
• Work Orders
• Microsoft Excel
• Clinical Data Management
• Manufacturing Operations
• Public Speaking
• Pharmaceutical Industry
• Biotechnology
• Filemaker
• Presentation Skills
• Microsoft Office
• Change Control
• Machine Operation
• Pharmaceutical Packaging
• File Management
• Bookkeeping
• Marketing Strategy
• Time & Attendance
• Credit Analysis
• Event Planning
• Project Management
• Course Creation
• Budgets
• Visual Inspection