Quality Assurance Development Manufacturing Engineer |
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SUMMARY OF QUALIFICATIONS
Over ** years of extensive experience in the Pharmaceutical , Nutraceutical and Medical Devices industry with primary focus on Formulation Development and research of new materials, medicated coatings, physical and analytical testing, process and product development
Competent working with MS Office Suite including Word, Excel, PowerPoint, Mini tab , comprehensive resource planning software as Track Wise , quality compliance software as JD Edwards, e-Synergy, Macola, Crystal Reporting and other statistical and equipment related software .
Excellent organizational, communication and interpersonal skills
Self-motivated, detail-oriented, problem recognition, and troubleshooting abilities, managing multiple projects, duties and assignments
Capable of multitasking and working well under pressure
AREAS OF STRENGTH
Knowledge of organic, analytical chemistry. Vitamins, supplement and herbal expertise.
Formulation and development of new products (Tablets, capsules and powders), based on customer's specifications, label and/or sample.
Development of Nutraceutical Formulations, Specs and QQFs. Preparation of Pilot scale batches for selection of formulation components and manufacturing processes.
Solubility, compatibility, and dissolution testing, stability studies.
Modification of existing formulations and performing of all necessary calculations for ingredient functionality, product functionality, product enhancement to improve quality, cost, and manufacturing of new and current products.
Reviewing of New and existing Master Formulas, creating of Master Batch records, Mixing Instructions and In-Process manufacturing Limits, supporting QA department as well as Production. Existing Batch Record reviews.
Laboratory analysis of raw materials, in process and finished products. Stability testing for samples and solutions, physical and analytical testing. Quantities and qualitative testing per quality standards.
Operation, maintenance, calibration and cleaning of laboratory equipment such as HPLC, UV, Gas Chromatography, computerized optical systems, INSTRON, various laser micrometers, hydraulic pressure equipment, vision system, Flow Cytometers, to ensure compliance with GLP
Strong Knowledge of GMP, SOPs, ISO, EN and FDA regulations and quality systems, company policies, safety rules and regulations.
Create documentation such as reports, test procedures, flowcharts, IQ, OQ and PQ, various protocols, SOPs and STPs. Statistical data analysis
Assisting with design of experiment, data management, data analysis and failure investigations
Providing guidance and training for employees
PROFESSIONAL EXPERIENCE
NATURES PRODUCTS, Inc Sunrise, Fl 2010-2012
Nutraceutical Formulation Chemist
New Formulations development and evaluations, SPECs/QQFs, Batch record review
Manufacturing Limits, Mixing Instructions, Master Batch records, Change Requests
Conducting Pilots, responding to Customers complains
Signing Technical Documents for Product Development Manager
NOVEN PHARMACEUTICAL, INC Miami, Fl 2009-2010
Quality Assurance/New materials and Components release
Review documentation, Certificates of Analyzes
Expiration date, new material, intermediate and finished goods release
AVEVA DRUG DELIVERY SYSTEMS, INC Miramar, Fl 2008-2009
Quality Assurance/Batch Record Reviewer/ Product release
Review documentation, Batch records and analytical data for accuracy, completeness and compliance to all requirements and cGMP
Create investigations; corrective and prevention actions reports
Product Release and Reject decisions
CORDIS CORP., JOHNSON & JOHNSON CO. Miami Lakes, FL 1996 - 2008
Research and Development/New Product Development Department
Polymers and materials research, investigations and tests development. Coating formulation, coating process development and implementing. New test method development and validation. Stability testing. PQ, IQ/OQ and process challenge testing. Conducted qualitative and quantitative tests per company standards, FDA submissions. Various protocols development and execution, final reports.
WORLD MEDICAL MANUFACTURING CORP., Sunrise, FL 1994 - 1996
Product development / R&D/ QC
RELATED EXPERIENCE
PROJECT ENGINEERING INSTITUTE, Gorky, Russia. Material Engineer-Technologist
BIOMEDICAL LABORATORY OF GORKY STATE UNIVERSITY, Gorky, Russia
Research project “Influence of Vitamins on Animal’s Body”. Preparation of experiments, observation, data analysis and report writing.
EDUCATION
GORKY ENGINEERING UNIVERSITY, DEPARTMENT OF TECHNOLOGY, Gorky, Russia Master’s Degree in Material Engineering (Evaluated to American standards)
AWARDS RECEIVED
J&J Achievement Award for Hydrophilic Coating Development. Patent for Coating Formulation is pending; Numerous Excellence Awards
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