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Quality Control Microsoft Office

Location:
Cranbury Township, New Jersey, United States
Salary:
65,000/yr
Posted:
October 19, 2016

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Resume:

Debra M Citrano

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

Cranbury, NJ 08512

516-***-****

acw5ag@r.postjobfree.com

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

EXPERIENCE

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

SUMMARY OF QUALIFICATIONS:

• 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.

EDUCATION

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

Hofstra University, Hempstead, NY; Major: Chemistry

ACCOMPLISHMENTS

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

PROFESSIONAL ACTIVITIES

Member of American Chemical Society

COMPUTER SKILLS

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



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