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Quality Control Microsoft Office

Cranbury Township, New Jersey, United States
October 19, 2016

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Debra M Citrano

*** ******* *******

Cranbury, NJ 08512


OBJECTIVE: Position in the pharmaceutical industry as a Quality Control Senior Analytical Chemist.


Porton USA

-Analytical Chemist (06/06/16-10/13/16)

• Set up of the startup laboratories for process chemistry manufacturing facility

• Analytical consultant for the non-GMP and GMP Analytical Lab setup

• Streamlined the laboratories for a full operation for the Porton USA Grand Opening tours

• Purchased equipment for analytical in-process walk up laboratory operation, including LC/MS, HPLC, UPLC, DSC, Karl Fisher Coulometer, GC, TGA, Analytical and Top loader Balances

• Documented Quality Control requirements for RFP’s and purchase required consumables to accommodate all analytical tests

• Reviewed outsourcing of testing labs for best prices and QC releases

• IQ/PQ/OQ for all lab equipment purchased and installed for walk up analytical lab

Obiter Research, LLC.

-Analytical Chemist/Quality Control (12/11-02/16)

• Develop new methods for synthesis of difficult compounds.

• Support Kilo Chemists in the scale-up process by analytical means to attain highly pure compounds.

• Calibrate analytical balances and equipment to stay in compliance with the industry standards.

• Release products with COA utilizing defined methods to assure quality products to customers.

• Write SOP’s for operations pertaining to Quality Control and Analytical processes.

• Documentation and record keeping for all products tested and released.

Contract Pharmacal Corporation

-R&D Chemist (1/10-3/11)

• Develop and Validate methods for Multi-Vitamins and solid dosage forms.

• Procurement of all laboratory supplies including HPLC, ICP and Dissolution apparatus maintenance and troubleshooting services.

• Performed analytical testing on finished products and stability samples, utilizing validated methods to support the manufacturing operations.

• Assist in training of new employees for analytical testing on products and with regards to safety and cGMP's requirements.

• Calibrations on all R&D Analytical Balances, Dissolution Apparatus and HPLC's within a timely manner so as not to affect production.

• Review documentation and laboratory notebooks for product release according to cGMP's

Quality Control Chemist (3/09-1/10)

• Performed analytical testing on finished products and stability samples, utilizing validated methods to support the manufacturing operations.

• Assist in training of new employees for analytical testing on products and with regards to safety and cGMP's requirements.

Tan Productions, Inc.

Account Executive (10/07-3/09)

• Sales for Polices Benevolent Association annual journals.

Material Testing Lab, Inc.

Senior Account Executive (4/06-9/06)

• Sales for Quality Testing Services for Construction Contracting Companies.

Hi-Tech Pharmacal, Amityville, NY

Quality Control Chemist (04/03-06/04)

• Responsible for release of various types of liquid dosage forms; syrup, lotions, emulsions, eye solutions, liquid baby vitamins

• Finished Product and stability release testing using HPLC, GC, UV, FTIR,

Kos Pharmaceuticals, Edison NJ

Quality Control Chemist II (01/03-04/03)

• Coordinated USP and EP testing with outside contract organizations to ensure cGMP compliance.

• Performed analytical testing on raw materials samples, utilizing validated methods to support the manufacturing operations.

• Analytical testing using Karl Fisher titration, HPLC, GC and wet chemistry USP methodology

DuPont Pharmaceuticals Company, Garden City, NY

Quality/Lead Scientist, Reference Material (02/91- 02/02)

• Orchestrated DuPont’s Reference Standard Program for domestic and international distributions with in accordance to regulatory guidance.

• Procurement and distribution of reference material according to EPA, DEA, and strict shipping guidelines

• Analytical testing to release reference materials for worldwide license markets usage

• Managed reference standard materials and provided inventory for corporate and international usage.

• Reviewed and assessed the impact of proposed compendia changes on Raw Materials and Finished Products.

• Provided analytical technology support for quality investigation and resolution.

• Created, implemented, and maintained internal SOPs based on regulatory standards.

• Participated in management level meeting to discuss and integrate strategies for DuPont’s Reference Standard Review Board.

Analytical Chemist (01/80-02/91)

• Audited raw materials and finished product release testing, method validation protocols and reports to ensure for cGMP compliance.

• Ensured that company products are in compliance with internal SOPs and regulatory guidelines

• Responsible for release of various types of solid and liquid dosage forms, R&D and stability product testing using HPLC, GC, UV, FTIR

• Performed analytical testing on finished products, stability samples, and raw materials utilizing validated methods to support the manufacturing operations.

Lory Industries, Deer Park, NY

-Defense Plant Chemist (09/79-1/80)

• Analysis of nitrocellulose shells for defense plant manufacturing

Endo Laboratories

-Laboratory Assistant (02/76-06/79)

• Performed clinical testing of various dosage forms on animals

• Prepared animal on study for necropsies and assisted with histology


• Twenty five+ years of professional experience using strong technical skills in a research and manufacturing environment.

• Dedication and tireless effort to ensure each project is completed on deadline.

• Provided sound scientific responses to resolve open investigation deviations.

• Ability to train new staff with an emphasis on cGMP and regulatory requirements.

• Support of customer and agency audits.

• Effective writing and documentation skills.

• Well versed in cGMP and regulatory compliance.


B.S., Almeda College and University, Major: Chemistry

Hofstra University, Hempstead, NY; Major: Chemistry


Marquis Who's Who in American Women, 24th Edition, 2004-2005

Manchester Who's Who Registry of Executives and Professionals, 2003-2004

American Biographical Institute, USA, Woman of the Year, 2004


Member of American Chemical Society


Microsoft Office, Microsoft Excel, LIMS, Multichrom, Empower, Agilent software, Shimadzu software, Adobe Acrobat and LAS

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