Quality Assurance Associate Resume Brooklyn, NY - Hire IT People

PROFESSIONAL SUMMARY:

More than 2 years of experience as an Associate Scientist Formulation & Technology Development, Quality Assurance Associate & Mixing Chemist gave tremendous hands on experience over scale-up, pre-formulation and formulation studies for solids, liquids, lyophilized, powder formulations of biological products and novel dosage forms.
Served as strong contributor tonew technology developmentactivities such as solubility enhancement, taste masking, rapid release and controlled release,scale-up of novel dosage forms and implementation ofanalytical methods, biochemical, bio analytical, physical characterization methods and stability and compatible studies of developed formulations.
Involved in HPLC assay methods, dissolution and disintegration tests and Involved in preparing and reviewing OQ, PQ protocols andSOPs for day to day functioning.
Performed complexation & stability studies, Preparations of buffer solutions & handle other Laboratory responsibilities include maintaininglaboratory equipmentsunder GLP conditions and recording data in notebooks and computer databases, per established procedures.
Experienced with project management by working on idea gate, discovery gate, definition gate and development gate.

PROFESSIONAL EXPERIENCE:

Confidential, Brooklyn, NY Jan'09 to Aug'09
Pharmaceutical Development Associate Scientist

Performed Experimental design for drug formulation strategy as well as Participate in a multi disciplinary team to plan and execute the formulation development, optimization, and scale-up of novel dosage forms.
Hands on experience with Fitz mill, Vibration Shafter, Super mixer Granulator, Super mixer Granulator dryer, Fluid bed dryer Granulator, V blender, Double cone mixer, Sugar coater, Roll compactor, Tablet Press & Analytical Equipments such
HPLC,DSC, USP- Disintegration apparatus, Dissolution apparatus & spectrophotometers.
Performed complexation & stability studies, Preparations of buffer solutions & handle other Laboratory responsibilities include maintaining laboratory equipments under GLP conditions and recording data in notebooks and computer databases, per established procedures.

Confidential, Jan'08 to Dec'08
Graduate Assistant

Working to answer Drug information questions from Health care Professionals with IDIC staff to do Comprehensive literature searches, drug evaluations. Organized seminars on scientific literature and Managed comprehensive library of resources includes numerous medical and pharmacy Journals, specialized texts, commercial electronic databases and I.D.I.C. made in-house database for varied requests for drug information & typical drug information inquiries.

Confidential, India May'06 to Nov'06
Mixing chemist

Worked in Class 100 area and maintaining BMR and OOS reports for both SVPs and LVPs.
Involved to conduct c GMP audits and inspection of high speed automated liquid and powder filling lines, lyophilization and BFS line for development, manufacture and control of injectable drugs.

Confidential, India Jan'06 to Aril'06
Quality Assurance Associate

Involved in HPLC assay methods, dissolution and disintegration tests and Involved in preparing and reviewing OQ, PQ protocols and SOPs for day to day functioning.

Confidential, India. Feb'05 to Dec'05
Formulation Technology & Development scientist

Performed PMF development, includes excipient selection, composition optimization, Performed DOE for drug formulation strategy and deciding next steps based on results.
Served as strong contributor to new technology development activities such as solubility enhancement, taste masking, rapid release and controlled release, scale-up of novel dosage forms and implementation of analytical methods, biochemical, bio analytical, physical characterization methods and stability and compatible studies of developed formulations.

TECHNICAL SKILLS:

Tablet Process Line: Fitz mill, Vibration Shafter, Super mixer Granulator, Super mixer Granulator dryer, Fluid bed dryer Granulator, V blender, Double cone mixer, Super film, Sugar coater, Roll compactor, Tablet Press
Liquid dosage form Line: Storage & mixing tank, Bottle washing machines, Brookfield Viscometer, PH meter, packing equipments.
Analytical Equipments: Scanning Electron Microscope, HPLC,DSC,USP- Disintegration apparatus, Dissolution apparatus, UV- Visible Spectrophotometer
Proficiency in MS Word, Power point, Excel, FoxPro, Operating systems(Windows 5/98/2000/2007/XP/Vista/Mac).

EDUCATION AND CERTIFICATION:

EDUCATION PROJECTS:

Presented seminars on "Sterile Products" & "Controlled Release Technology & Drug Targeting".
Seminar on "Matrix Formulation of Controlled Release Dosage Forms" & "The Preparation of a Solid Dispersion
Powder of Indomethacin with Cross-povidone using Twin-Screw Extruder or Kneader."