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Quality Control

Location:
Shrewsbury, MA
Posted:
May 11, 2013

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Resume:

SONAK DALAL

** ******** *****, ***. *, Shrewsbury, Massachusetts 01545

201-***-****

abus0g@r.postjobfree.com

Eleven years of professional experience in diverse chemical laboratories

covering various roles. Expert analytical minded chemist with extensive

experience of numerous laboratory instruments. Excellent organization &

innovative ideas for problem solving skills to manage and train a team of

technicians and carry out various operations and experiments successfully.

Vast experience working efficiently and effectively in a fast paced high

throughput environment with strong attention to detail.

OBJECTIVE

Looking for a challenging, creative role to work on projects in the field

of chemistry and implement the expertise and experience previously gained

to develop quality products useful for the organization.

Willing to Relocate.

EDUCATION

UNIVERSITY OF SCRANTON, Scranton, Pennsylvania, USA

Master of Arts in Biochemistry, August 2001 - August 2004

. Merit based Scholarship

UNIVERSITY OF MUMBAI, Mumbai, Maharashtra, INDIA

Bachelor of Science in Chemistry, August 1994 - May 1997

. Graduated top 25%

ANALYTICAL EXPERTISE

. Inductively Coupled Plasma Mass Spectrometry (ICPMS)

. Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES)

. Atomic Absorption Spectroscopy (AAS)

. High Performance Liquid Chromatography (HPLC)

. Gas Chromatography (GC)

. Fourier Transform Infrared (FTIR) Spectroscopy with Attenuated Total

Reflectance (ATR) accessory

. Thermo Gravimetric Analyzer (TGA)

. Ultraviolet-Visible Absorption Spectroscopy (UV-AS)

. Particle Size Analyzer

. Hoover Automatic Muller

. Color spectrophotometer

. High Performance Stability Analyzer

. Geiger-Muller Counter

. Fluorescence Spectrophotometer

. Scanning Electron Microscope (SEM)

. Sun Protection Factor (SPF) Analyzer

. pH meter

. Conductivity meter

. Gloss meter

. Refractometer

. Hydrometer

PROFESSIONAL EXPERIENCE

ANALYTICAL CHEMIST, US Cosmetics Corporation, Dayville, CT (February 2011 -

Current)

. Perform sampling, physical & chemical testing such as oil absorption,

bulk density, apparent density, tapped density, refractive index,

specific gravity, loss of drying, loss on ignition, water soluble

matters, acid soluble matters, IPA soluble matters, hydrophobicity /

Hydrophilicity, meshing, pH, conductivity, viscosity, particle size

distribution, hydrogen potential, analyze drug active ingredient in

product by HPLC, infrared spectrum of absorption by FTIR using ATR

crystal technique, color comparison by Drawdown and spectrophotometer,

gloss, % transmittance, absorbance, ionizing radiation testing involved

in quality control and product development.

. Perform microbiological analysis of cosmetic raw material and finished

product for bacteria, fungi and other microorganism. Identification of

contaminants using morphological characterizations based on selective and

differential media growth and direct microscopic characterization and

utilization of BioMerieux's API system

. Perform Microbial testing of water samples using Milliflex Millipore

Membrane filtration device.

SONAK DALAL - Resume (Continued) Page 2

. Perform executed Batch Production Control Record (BPCR) review to ensure

compliance with approved procedures and GMP expectations. Review release

test and stability data ensuring data accuracy, conformance to test

procedures, specifications and documentation standards and approval of

Certificate of Analysis for lot release and managing implementation of

required changes to meet GMP and internal standards. Provide support for

resolution of nonconformance, deviations and other investigations.

. Conduct instrument qualification, validation and calibration including

IQ/OQ/PQ and 21-CFR Part 11 compliance.

. Establish and Coordinate automated instrument (Performance Maintenance)

PM and services.

. Develop and monitor stability study protocols to ensure complete and

accurate data for shelf life and expiration dates for all products and in

process materials.

. Study the Root Cause Analysis (RCA) and fill up vendor's or supplier's

Corrective & Preventive Action (CAPA) forms.

. Write qualification protocols, reports, methods, standard operation

procedures (SOP's) for new automation equipment and processes in the

analytical laboratory and submission documents.

. Coordinate team activities by setting priorities with immediate

supervisor. Develop strategy for implementing automation across

development groups, setting goals and objectives and tracking efficiency

metrics.

. Develop, improve and customize products, equipments, formulas, processes

and analytical methods for implementing solutions of technical problems.

. Utilize advanced computer software and chemistry knowledge and a wide

variety of sophisticated laboratory instrumentation for modeling and

simulation in work.

. Conduct qualitative and quantitative chemical analyses of research

projects to develop and improve manufactured products and prepare

standards and specifications for purposes such as Research & Development

(R&D)

. Confer with other chemists, scientists and engineers regarding research

and prepare analyses, interpret test results or develop nonstandard test.

. Read, analyze and interpret complex information and present complex

chemical concepts and conclusions via reports.

. Document and report results of studies includes: study reports, figures,

appendices and tables.

. Revise how our company currently maintains our analytical tests results

in forms of databases which will benefit future R&D activities in various

aspects.

. Responsible for monthly trending reports of QC Quality Metrics- Raw

material, Finished Product Quality tests, Finished Product Microbial

Tests, Product Return, Near Miss, Quality Incident and Rejection.

. Evaluate, recommend and implement new analytical technologies.

ANALYTICAL CHEMIST, Noble Biomaterials, Inc. Scranton, PA (October 2007 -

November 2010)

(ISO 9001:2008 certified)

. Maintain task sheet of technicians to monitor their daily activity and

results. Took responsibility of analyzing and interpreting final results

from the results given by technicians on various tests conducted in

laboratories as specified under my guidance. Help technicians in times of

difficulty in troubleshooting instrument errors, performance and

experiment and make sure that the whole process is carried out

efficiently, effectively and successfully on time.

. Utilize my in depth knowledge to use latest analytical techniques and

tools for testing products developed to determine whether they meet the

product specification and record for any discrepancy.

. Analytical Method Development and Validation, Implement Six Sigma

Methodology on projects to reduce variability, defects, downtime, and

waste and to increase productivity and efficiency.

. Utilize EPA method for sample preparation by digestion on hotplate,

incubation for elemental Ion Release in Incubator or Shaking Water Bath

for elemental analysis by ICP-OES Optima 7000 series or AAS AAnalyst 300

series.

. Use ODBC (Open Database Connectivity) compliant software-InfinityQS

ProFicient for SPC (Statistical Process Control) - Collection, real-time

quality analysis, Innovative Control Charting of data.

. Maintain ISO documents, analysis sheets filled by technicians in

laboratory for future reference.

. Maintain the inventories of instrument parts for Maintenance, chemicals,

Standard Reference solutions, Lab accessories needed and placed order at

appropriate times which help technicians to carry out the experiments

smoothly.

. Perform and maintain Log sheets of Daily optimization, routine

performance maintenance, preventive maintenance and troubleshooting of

analytical instruments.

. Write, review and update standard operating procedures and design testing

forms as necessary. Authorize and revise specification documents at

management's direction.

. Analyze Waste Water Treatment Samples, perform Soxhlet Extraction

technique and Excellent ability on experimental operation and complete

the research projects independently.

SONAK DALAL - Resume (Continued) Page 3

ANALYTICAL CHEMIST, Eagle Nutritionals, Carlstadt, NJ (September 2004 -

September 2007)

. Analytical Development: Troubleshoot basic assay or instrumentation

issues.

. Product Analysis: in depth knowledge of operating analytical instruments

such as ICPMS, HPLC, FTIR, AAS, Microwave Digestion and other standard

laboratory equipment relevant to job responsibilities to service in-

process and finished product in accordance to standard procedures.

. Understand and precisely follow written laboratory procedures, global

methods, local in-house methods and published standard or compendia

sources.

. Calibrate and maintain analytical instruments and the use of analytical

reference standards relevant to job description.

. Develop Standard Operating Procedures and Formulation Development as

required by clients.

. Use laboratory safety equipment and understand precautions in handling

reagents and disposal of chemical waste according to local environment

regulations.

. Perform necessary adjustments to in-process batches when an out of

specification result is identified by calculating accurate additions to

the batch using the test results as a baseline.

. Communicate the required addition to the operations department who

performs the adjustments and the resulting sample tested again to

determine compliance to specification.

. Collect and analyze test data to identify root cause, draw conclusions

and recommend actions.

. Issue Certificate of Analysis for Food Supplements.

. Send Samples to Clients for shape, size, color, taste approval.

. Physical test: Dissolution, Disintegration, Thickness, Hardness,

Friability, Uniformity & Color Match of tablets.

. Prepping standards, mobile phase, stocking the Lab, maintain accurate, up

to date and concise laboratory notebooks & records and any other general

Lab duties required to run the Lab.

RESEARCH ASSISTANT, Chemistry Department, University of Scranton (May 2002

- August 2004)

. Analytical method development, stability and process validation.

. Determination of Selenium in plasma by comparative Human Absorption of

Selenium using AAS. Collected blood sample from subjects at different

time intervals. Ran all the standard and extracted plasma samples in AAS

using Furnace technique to find amount of Selenium in plasma.

. Determination of Coenzyme Q10 in plasma by comparative Human

Bioavailability using HPLC. Compared the antioxidant effectiveness using

an in vitro model of lipoprotein oxidation. Collected blood sample from

subjects at different time intervals. Ran all the standard and extracted

plasma samples in HPLC to find amount of Coenzyme Q10 in plasma.

o Research work presented as a poster, which was awarded first prize at

Natural Supplements in Evidence-Based Practice at La Jolla,

California.

. Determination of alpha tocopherol (Vitamin E) in plasma using HPLC.

GRADUATE ASSISTANT, Chemistry Department, University of Scranton (August

2001 - June 2003)

. Instructed general chemistry labs to undergraduate students with an

emphasis on developing full subject knowledge.

. Oversaw 40-42 students during weekly three-hour lab periods conducted

according to the syllabus and corresponding text.

. Communicated and ensured adherence to all safety rules and regulations.

. Evaluated and assigned grades based upon administration of weekly safety

/ procedural quizzes, laboratory techniques / performance, and laboratory

reports.

. Personal interaction with students to facilitate learning.

STUDENT CONSULTANT, Information Resources Help Desk, University of

Scranton (July 2002 - August 2004)

. Provide Technical Support / troubleshoot technology related problems for

the University community via telephone, walk- up, in classrooms and at

special events in the use of network, audiovisual equipment and systems.

REFERENCES

. Professional and personal references provided upon request.



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