Quality Assurance Development

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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