Manager Quality Control
Resume:
Elizabeth B. Castro
North Hollywood, CA 91601
************@*****.***
Objective
To obtain a Project Development or Technical Support position enabling me to be hands-on while utilizing my Regulatory and Technical background and experience. Professional Experience
DERMA E Simi Valley, CA
Product Development/Regulatory Affairs Manager 9/2017 – Present
• Oversee the product development process from new product initiation to completion of production for all new product launches and reformulations.
• Brief vendors on COG targets and timing to suppliers for full turnkey assembly and request quotations based on estimated forecasting and MOQs.
• Collaborate with cross functional teams (development, creative, sales, marketing and operations) for product launch strategies and execution.
• Participate in the identification of needs for new products; approving all materials developed in support of programs; reviewing, editing, and approving all copy; ensuring legal requirements are met for product names and product claims.
• Collaborate with the creative and marketing teams for product concepts and design.
• Ensure all regulatory requirements are met throughout the development process.
• Review new product advertising and marketing material for compliance to regulatory requirements and laws.
Quality & Regulatory Affairs Manager 5/2016 – 9/2017
• Provide strategy and direction for regulatory pathways related to new products, claims and international sales strategies for product registrations to enable global market success.
• Monitor formula changes and label revisions to assure regulatory compliance based on an understanding of applicable regulations and internal company standards.
• Review and approval of product packaging to ensure compliance.
• Work with outside vendors, marketing and procurement on new product concepts to ensure regulatory compliance to all applicable regulations (FDA, Canada, etc.).
• Complete submissions to FDA, Canada and other regulatory agencies in a timely manner.
• Prepare and update domestic and/or international ingredient listings as needed.
• Supervise regulatory consultants in the preparation and maintenance of international product registrations.
• Perform 3rd party analysis and safety testing.
• Manage the vendor internal and external audit program and assist with audits when applicable
• Inspection of all incoming products and packing to ensure compliance to internal quality standards and product masters.
Hugo & Debra Naturals Chatsworth, CA
Quality Control & Regulatory Affairs Specialist 1/2016 – 4/2016
• Maintained company SOPs and the Document and Change Control System.
• Responsible for day-to-day management and review of laboratory and regulatory data.
• Worked closely with the Director of Operations to ensure compliance with Cosmetic GMP’s and OSHA requirements.
• Developed and prepared accurate technical information for product labeling and marketing materials.
• Responsible for the implementation of corrective actions and response reports for audits.
• Responsible for cGMP training.
Regulatory Affairs Consultant 9/2015 – 1/2016
• Provided leadership and support to Company personnel while ensuring compliance with international and domestic regulations through project management and delegation of tasks to ensure new brand launch.
• Performed compliance review of all ingredients, product formulas and labeling to all applicable standards.
• Partnered with R&D, marketing, procurement, production and packaging to resolve compliance issues.
Personal Care Resource Group Chatsworth, CA
Regulatory Affairs Consultant 9/2014 – 9/2015
• Assumed responsibility for international product registration for exportation of cosmetics as well as dossier preparation.
• Handled all regulatory customer correspondence.
• Facilitated product reviews, including risk assessments for formulations and labeling for compliance to all applicable standards.
A Plus EJ Services Van Nuys, CA
Operations Assistant 8/2013 – 9/2014
• Provided full range administrative, technical, and support functions for CEO as required.
• Initiated and implemented social marketing strategy (i.e. Yelp, Facebook and Craigslist) to increase client leads and to establish company awareness.
• Coordinated with web designer for website design and optimization of organic search.
• Responsible for developing and preparing of KPI’s reports including freight costs, transit times, service failures and customer feedback. Chemsil Silicones, Inc. Chatsworth, CA
Quality Control & Regulatory Affairs Manager 11/2007 – 7/2013
• Assisted customers and clients with product development by creating formulations based on customer requirements and/or by recommending products based the open market.
• Formulated R&D personal care products.
• Performed stability studies on new products as well as customer-specific formulations.
• Created testing protocols and reports to support patent claims.
• Created and implemented company SOPs.
• Created product specifications, GHS compliant Safety Data Sheets, and Certificates of Analyses for manufactured finished products and/or customer lab formulations.
• Responsible for training lab staff and troubleshooting any testing issues.
• Collected and maintained all quality control data to perform trend analysis to assist with Root Cause / Corrective Action investigations.
• Represented the company during third-party audits
• Prepared supporting documentation for the exportation and international registration of products including tariff codes.
• Assisted customers is compiling and/or creating documents to ensure compliance with current international personal care regulations.
• Acted as the company’s REACH liaison.
Quality Lab Supervisor
• Ensured accurate and timely analysis of incoming raw materials and finished product samples.
• Performed In-process and Finished Goods testing for manufactured batches using Brookfield Viscometers, FT-IR, and Ohaus Moisture Analyzers.
• Worked closely with Production to improve mixing processes and reduce rejects.
• Verified production batch tickets and close the batch in the inventory system upon acceptable QC results.
• Ensured compliance with GMP.
LA Testing S. Pasadena, CA
Lab Quality Control Supervisor 8/2005 – 10/2007
• Responsible for ensuring all quality control procedures are performed at required frequencies and maintain data for reporting to lab manager.
• Collected and maintained all quality control data from other analysts and prepare monthly and quarterly reports using appropriate statistical tools.
• Ensured that the laboratory maintains compliance with the policies and procedures documented in the company Quality Control Manual.
• Performed periodic reviews of final data reports.
• Assisted in State, Federal and Industry-specific audits. Chemistry Lab Coordinator
• Management of multiple projects on a daily basis and responsible for meeting various time deadlines.
• Supervision over two other analysts.
• Analyzed samples by Flame Atomic Absorption and entered results into company LIMS system.
• Increased lead lab production 10% from 2005 to 2006. Education
Armstrong Atlantic State University Savannah, GA
Bachelor of Science in Chemistry May 2005
Georgia Southern University Statesboro, GA
Master’s in Business Administration May 2009
Publications
Baker, E.; Dyal, C.; Harris, B.; Miller, J.; Moore, J.; Lynch, W. E.; Nivens, D. A. “Materials Based Laboratory – Intercalation of Organic Materials and Polymers Into Minerals.” The Chemical Educator 2006, 11(5), 321-324.
References
Available upon request
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