Quality Manager

Anita V. Patel

*** ****** ****** • Mount Kisco, NY 10549

914-***-**** * Email: *********@*****.***

OBJECTIVE: Position as a Senior Scientist, Associate, Senior Quality Assurance Auditor, Data Entry Store Manager, Administrative Assistant, Sales Associate Labeling Associate or Laboratory Technician

SUMMARY

Auditor and Analyst with extensive experience with documentation and relevant experience with various chromatographic separation techniques and instrumentation. Work effectively with members of other departments and functions to achieve cross-functional goals. Proven success learning new skills and technologies quickly and accurately. Work well in computer technologies. Detailed knowledge about Excel. Insert statistical functions, Autosum, Insert various types of charts such as column, line, pie, bar, area, scatter and other charts. To prepare charts select values. I used to prepare sterile purchase orders for Medical devices at Dynarex corporation.

TECHNICAL & SPECIALIZED SKILLS

CGMP, LIMS, Trackwise, GXPharma, Totalchrom, Empower, TC Publisher Reports. Various Analytical Pharmaceutical Techniques.

HPLC HP 1090, HP 1050, Waters 2695 Separation Module, Waters 2487 Dual Absorbance Detector, Waters 486 Tumable Absorbance Detector, Hitachi pump

GC HP5890, HP 6890, HP Injector Model # 79855A

IC DX300, DX500 Dionex.

HPSEC Waters 712 wisp, Waters 590 HPLC pump, Waters 410 Differential Refractometer, Trisec, Wisp 710B, Hitachi and GBC pump, T50A Differential Refractometer

ANTEK Pyroluminescent Nitrogen and Sulfur, Infrared Spectrophotometer, UVA/IS Spectrophotometer

PROFESSIONAL EXPERIENCE

Trustco Bank, Mount Kisco, N.Y. 9/2014 – 3/2015

Teller

Work as a Teller position handling cash, deposit, withdrawal as well as pass book transactions and many more functions. Prepared Teller proof sheet everyday and used sharp machine for audit trail. Cash and checks handling as well as complex transactions. Passed Teller training as well as regulatory and compliance trainings.

Dynarex Corporation, Orangeburg, N.Y. 5/ 2011 - 5/2013 Quality Associate

Preparation of Device Master Record for Medical Devices using Quality rules and regulations. Performing some Laboratory work as well. Following Health and Human services rules and regulations. Prepare Certificate of Compliance, Certificate of Analysis, Certificate of sterilization. Prepare Purchase orders for sterile products. Review FDA site to determine Product codes, Device types, Company's certification etc. Determine Medical Devices for gram per meter squares. Work as a Document control person. I also have experience with incoming FDA inspection labeling for drug and medical devices. I prevented possible non-conformance and recall in auditing the labeling of a drug product. I have about two years of experience working as a labeling associate. I have extensive experience auditing Labeling for various drug products containing NDC numbers and other details. Regulatory Labeling Associate experience auditing NDC number DIN number for Canada, Active Ingredients, Inactive ingredients, Drug facts and following all FDA and Health and Human services rules and regulations. Manage approval and Proof read of Packaging Artwork. Good knowledge of Word.

ANITA V. PATEL 914-***-****

TEVA PHARMACEUTICAL INC. (formerly Barr), Pomona, NY 1/ 2003 -3/ 2010

Auditor II

Audit data with Quality and compliance following SOPs, Methods, Rports, protocols etc. Quality audits by using software knowledge for chromatography data acquisition systems such as Totalchrom, Empower as well as LIMS. Raw Material Audits, Finished products Audits, Stability Audits, Metrology Audits.Method transfer Audits etc. Knowledge about Barr SOPs, Teva SOPs. Audits for chromatography such as GC, HPLC and other Techniques. Knowledge to interprete data with Quality and Compliance following FDA Rules and Regulations. Learn Trackwise software.

ANITA V. PATEL 914-***-****

Took some more Trainings related to Job Requirements. Became a Team player. Demonstrate resourcefulness and initiative in executing job functions, suggested process improvements and solutions and make decisions in Timely Manner.Openness to and able to manage changes in response to new challenges and opportunities. Continually search for ways to increase customer satisfaction and work diligently to shape the organization, resources and processes to strengthen relationships with customers and gain their loyalty.

•Avoided potential FDA citation by correcting Residual Solvents GC Method.

•Ensured accuracy of future products releases by correcting LIMS Templates.

•Participate actively in Qualify Audits and suggestions for less deviations and better cycle time.

•Participate actively following CGMP, FDA Rules and Regulations and SOP-390 to close deviations successfully in LIMS.

•Ensured accuracy of Future products releases by correcting Totalchrom Methods for Standard amounts, Retention times, Relative retention times. Relative retention factors etc.

•Ensured accuracy of future products release by correcting TC Publisher Reports for functions such as Multiplies, Division Area%, LC% etc.

•Ensured Quality data by correcting Celsis Lab data for chromatographic calculations such as GC, HPLC and Atomic Absorption data.

•I have helped manufacturing department transfering methods, GMP work, Internal Audits, work as a Compliance specialist Work closely with Quality Assurance and CGMP departments.

SAN-MAR LABORATORIES INC., Elmsford, NY 2000-2003

Quality Control Manager 1/2001-1/2003

Raw Material Analysis using USP NF, SOP, IR, UV /Vis, PH Meter, Balance, Bulk and Finished products Analysis using HPLC, GC.

•Generated additional revenue by Modification in Chloraseptic HPLC Analytical Method.

•Collaborated w/Taro Pharmaceutical Inc. by performing Method Transfer by HPLC in Benadryl cream successfully and improving extraction Method followed by HPLC Analysis.

•I have trained several people in instrumentation and software skills. I trained new hires in various areas.

•I used to take care of Batch Record Review and write reports. I was documentation person. I handled FDA and EPA inspections.

ANITA V. PATEL 914-***-****

CYTEC INDUSTRIES INC., Stamford, CT 1991-2000

Chemist 1/1992-1/2000

•HPLC, GC, HPSEC, and IC data with excellent turnaround time to key customers by using automated calculation method for PE NELSON data acquisition system resulting in time saving to the company.

•Improved purity correction 3% using HPLC Analytical Method brought up the yield for the product resulted in revenue to the company. (UV5411, UV2337 Projects.)

LABS AND RESEARCH, Valhalla, N.Y 1/1985 -1/1988

Assistant Environmental Chemist

Analyzed aromatic hydrocarbons by PID, Halogenated Hydrocarbons by HALL and PNA by HPLC by using EPA methods.

•Set up an Automated Purge and Trap system for PID and HALL Detector saving time and money to the company.

•Passed NY State Exam for Assistant Environmental Chemist

EDUCATION and TRAINING

Master of Science in Chemistry, Gujarat University, India

Accredited by International Education Research Foundation, Inc. California.

Associate Degree in Computer Science, Westchester Business Institute, White Plains, NY

PROFESSIONAL DEVELOPMENT

Skills: Total Chrom, Empower, PE NELSON data acquisition system, Microsoft Word, Dionex Peaknet chromatography workstation, Excel, Millenium Software. HPLC Method development - LC Resources, Theory and practice of SEC - Waters, Triple Detection - Viscotek, Ion chromatography Theory and Troubleshooting - Dionex.

85-4453-1

INTERNATIONAL EDUCATION RESEARCH FOUNDATION, Inc.

P.O. BOX 24040, LOS ANGELES, CALIFORNIA 90024 213-***-**** CREDENTIALS EVALUATION SERVICE

December 27, 1985

Westchester County Department of Laboratories

and Research Hammond House Road Valhalla, New York 10595

Re: Anita V. Patel Gentlemen:

On the basis of credentials on file with this Service, we certify that Anita V. Patel, who has submitted records under the name of Anitakumari V. Patel, has completed studies (1977-82) at Gujarat University, located in Ahmedabad, India, earning the degrees of Bachelor of Science and Master of Science, which studies are considered equivalent in level and purpose to a Master of Science in Chemistry, granted by accredited colleges and universities in the United States.

Only work completed beyond Standard 12 is considered to be at the college or university level. This is in accordance with the placement recommendations approved by the National Council on the Evaluation of Foreign Educational Credentials, which are followed by most accredited colleges and universities in the United States.

The following courses were included in her studies:

Language

English (9A-, A.5B) 13.5

Science

Organic Chemistry (16A, 10A-) Inorganic

Chemistry (16A, 10A-) Physical Chemistry (16A, 10A-)

Physics (19A) Biology (9.5A) Organic Chemistry -

Dyes (30B) 136,5

TOTAL SEMESTER UNITS 150.0

OVERALL GRADE POINT AVERAGE 3.64

Very truly yours,

(Mrs.) Inez H. Sepmeyer

President IHS:grc c: Mrs. Patel

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