•Review and analyze labeling materials to provide regulatory strategy and compliance inputs•Assist with promotional content development and review for compliance before distribution•Provides oversight of workflows in support of expiration dates and periodic reviews•Determine and communicate approval requirements to cross functional teams

•Utilize QMS system (Veeva Software) to reviewing document content to ensure changes are appropriately following defined processes/procedures•Global support of US, GSM & EMEA documentation for Class III medical device, to assure that records are readily retrievable and in inspection-ready condition•Create, review and approve change requests•Collect data to generate report metrics and document retrieval for CAPAs

•Document control verification like (batch release, hold, CAPA, NCR & labels)•Assists with the review of manufacturing, environmental monitoring and quality control data for in-process and finished products•Ensure all records are documented and justified in accordance with procedural requirements in case of audits•Works closely with operating entities to facilitate trainings and assess impacts for continuous improvement

•Effectively worked with cross-functional team (e.g. R&D, Regulatory, Operations, Quality, Marketing) to develop labeling and packaging that meets the FDA requirements and manufacturing specifications•support product specification compliance and label claims•Experienced with Label Insight for product E-Commerce labeling •Reviewed and approved supplier documentations for compliance before release •Support new product launch by obtaining the information to develop the initial artwork

•Reviewed and proof read the package and label contents (label claims, ingredients, formulations) of OTC dietary supplements•Interfaced with contract manufacturers and suppliers of incoming raw materials for QA documentation•Cross checked on Artwork approvals (Supplement Facts, ingredient statement, claims, allergens, warning - safety statements, and nutritional information) with Global stewardship and R&D departments•Reviewed changes to existing products for safety/risk information (BE, GRAS, Non GMO, Allergens)•Create and manage change control packages in product life cycle management system, and ensure that documentation is accurate, appropriate, and justified

•Performed & reviewed batch records for in-process and finished products to release•Monitor COA confirmation testing and maintain active certifications with various 3rd party suppliers•Maintain product complaints log to identify & report Recurring issues•Quality review of complaint records to ensure that records are complete and accurate•Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met

•Assisted in all labelling activities, including label development through Genesis Software•Generated nutritional fact labels and ingredient declarations in compliance with CFR title 21 •Developed Calorie menu for all restaurant retail products

•Created promotional nutritional brochures based on local and federal regulations for needed vitamins, minerals and their benefits in infant formulas to be presented to pediatricians