Customer Service Quality Control

SUMMARY OF QUALIFICATIONS:

Over twelve years of experience in a cGMP environment

Primary objective is to assure product quality and integrity

Supervisory experience in a Quality Control laboratory

Strong teamwork and interpersonal skills

Implement cost savings through in-house testing

Develop and execute laboratory business plans and budgets

Create goals and work assignments for direct reports

Experience in method validation and qualification

Perform training on validated instrumentation

Perform maintenance and calibration of laboratory instrumentation

Excellent documentation skills per current compendial and GMP/GLP regulations

Strong time management and communication skills

Exceptional problem solving ability

EDUCATION:

1/94 – 7/03 State University of New York – Purchase College Purchase, NY

B.S. Degree in Chemistry / Environmental Chemistry

9/90 - 5/93 Dutchess Community College Poughkeepsie, NY

Biology

9/86 - 5/90 Dutchess Community College Poughkeepsie, NY

Architectural Technology

WORK EXPERIENCE:

MannKind Corporation Danbury, CT

May 2007 – April 2011 Supervisor – Quality Control Raw Materials

• Managed a diverse group of up to 12 chemists and technicians

• Evaluated and developed specifications, methods, and SOPs for new products and analytical instruments

• Created training modules of new test procedures

• Developed departmental schedules and organized testing of raw materials

• Represented the department on cross-functional project teams

• Mentored and recommended the advancement of individuals within the group

• Implemented cost saving strategies for the department by developing in-house test procedures

• Reviewed analytical data and approved documentation for release

• Perform validation and qualification of laboratory instrumentation, including IQ/OQ/PQ

• Perform basic calibration / maintenance of HPLC systems, including Agilent and Waters

• Prepare liquid/solid samples and standards for autosampler and manual injection

• Utilize chromatographic data handling software (ChemStation, Empower, Chromeleon, etc)

• Troubleshoot Instrumentation concerns

• Create data collection method and sample sequence

• Interpret and identify chromatographic component peaks

• Build multi-level calibration including external and internal standard calibrations

MannKind Corporation Danbury, CT

December 2005 – May 2007 Analyst III – Cleaning Validation

• Created a Cleaning Validation Master Plan for Clinical Manufacturing

• Drafted a Cleaning Verification Master Plan protocol for Chemical Manufacturing

• Lead groups in the development and validation of methods for a Cleaning Validation Program

• Developed swab and rinse sampling techniques based on manufacturing equipment constraints

• Executed SOPs and Test Methods for Cleaning Validation analytical testing

• Performed method transfer, both in method originating lab and method receiving lab

• Trained analysts and manufacturing staff on analytical testing and aseptic sampling

MannKind Corporation Danbury, CT

May 2005 – November 2005 QC Analyst III – Finished Product

• Performed routine testing of Technosphere/Insulin

• Analyzed samples of finished product by Cascade Impaction and Emitted Dose Techniques

• Analyzed samples of Bulk and Finished Product by HPLC, GC, FTIR and LOD

• Performed In-Process testing of Raw Material Insulin

• Responsible for peer / cross review of analytical data

Watson Pharmaceutical Carmel, NY

July 2003 – April 2005 Analytical Research & Development – Scientist III

• Supervised a group of analysts on performance of routine duties

• Method Development/Validation, Method Comparisons/Transfers of new ANDA products including API, Solid Dose Finished Products, and Excipients by HPLC, GC, and UV analysis

• Stability testing of Exhibit Finished Product Batches

• Physical testing of Raw Material by FTIR, HPLC, GC, and Particle Size

• Created and updated current SOPs, policies, and laboratory related reports

• Performed validation and calibration of laboratory equipment

• Performed analyses from USP, BP, NF, and company approved analytical test methods

• Responsible for writing Method Development/Validation and Research Reports

• Conducted training of new analysts on laboratory equipment and procedures

Watson Pharmaceutical Carmel, NY

November 1999 – July 2003 Laboratory Technical Services – Scientist II

• Performed quantitative and qualitative analyses of In-House Reference Standards

• Method Development/Validation, Method Comparisons/Transfers, and routine analysis of Raw Material, In-Process and Finished Product samples by HPLC and UV.

• Recorded and audited data in laboratory notebooks and on approved analytical worksheets in order to maintain records of experimental testing

• Calibrated equipment to ensure compliance with cGLP and cGMP

• Performed analyses from the United States Pharmacopoeia (USP), British Pharmacopoeia (BP), National Formulary (NF), and company approved analytical test methods

Watson Pharmaceutical Carmel, NY

July 1997 – October 1999 Analyst II – Dissolution Group

• Conducted HPLC analyses, extractions and timed reactions of multi-component finished products

• Performed routine testing of finished product and stability batches by HPLC and UV analysis

• Operated and maintained laboratory equipment according to current SOPs

• Assisted in the collection and disposal of hazardous material generated in the laboratory

United Skyport Corporation Westchester County Airport

September 1995 – August 1997 Service Technician

• Assisted in ground inspections and supervised the fueling and maintenance of aircraft

• Maintained scheduling for ground maintenance equipment and clean-ups

• Customer Service

Paul Krause – Architect & Bert Brosmith – Architect Katonah & Pound Ridge, NY

August 1987 – September 1995 Architectural Apprentice

• Performed residential and landscape designs

• Created and reviewed job proposals and ensured quality blueprinting

• Provided professional customer service to potential clients and business associates

• Assisted in all phases of construction

SKILLS:

• Computer Experience: Proficient with Microsoft Word, Excel, Power Point. TrackWise, Great Plains, JMP, e-InfoTree, Blue Mountain/Cal Man

• Instrumentation: Proficient in Empower and Millennium analytical data acquisition software; Hewlett Packard HP Chemstation, including the use of Agilent / Waters HPLC, UV and FTIR Spectrometry, Karl Fischer Moisture Determination, Potentiometric titrations, Particle Size Analyzer, and Volatile Organic Impurities by Gas Chromatography analysis. Purified water analysis by TOC and conductivity, TLC, Distek and Hansen automated Dissolution analysis.

• Analytical: Wet chemistry analyses per USP/NF monograph. Method development and validation of API, Stability-Indicating Assay, Cleaning Validation.

• Research: Conducted and evaluated the application of Solid Phase Microextraction in conjunction with GC-MS in the assessment of the environmental quality at the Kessman/Cross County Landfill in Patterson, New York, with respect to volatile and semi-volatile organic contamination.

REFERENCES: Furnished upon request

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