Data Project

HEMALI SARAIYA

E-mail: ********@*****.*** Cell Phone # 847-***-****

LinkedIn: www.linkedin.com/pub/hemali-saraiya/32/246/195/

Address: *** *** ** ******,** 60143

Qualification Summary

Excellent communicator ability to handle multitasks and delegates multiple assignments within fast-paced, deadline-driven environments.

Ambitious self-starter who demonstrates superior attention-to-detail.

Identifies employee training needs and follow through to accomplish the desired results.

Maintains QC Micro Lab equipment, including calibration documents.

Able to work independently and with a team.

Ability to work with cross-functional teams.

Excellent project management quality.

Able to work well under pressure and meet client deadlines.

Statistical programming related to the design, programming, implementation, maintenance, and validation of Clinical trial information for the submission to the FDA during various phases.

Skilled in Base SAS, SAS/SQL, SAS/REPORT, SAS/TABULATE and MACROS.

Skilled in using SAS/STAT procedures.

Good experience producing high resolution graphs using SAS/Graph.

Experience working with SAS/ODS and SAS/ACCESS

Experience in SAS Programming activities like merging SAS datasets, developing SAS procedures, data cleaning, report writing, macros, formats, informats, functions, storing and managing data in SAS Files.

Experience in using SAS to read, write, IMPORT and EXPORT to another data file formats, including delimited files, Spreadsheet, Microsoft Excel and access tables

Involvement in debugging the program using MPRINT and MLOGIC.

Knowledge on data mining.

Knowledge in Integrated Summaries of Efficacy (ISE) and Safety (ISS) according to Statistical Analysis Plan (SAP) and protocols.

Familiar with FDA regulations and ICH/GCP guidelines and requirements.

Familiar with terminology in Biology, Cell/molecular Biology, Oncology, Chemistry and Biochemistry.

Core Competencies

SKILLS

SAS Tools: SAS 9.1/9.2, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS/ODS

SAS Procedures: Proc Print, Means, Univariate, Report, Summary, Tabulate, Freq, Sort, Format, Copy, Compare, Gplot, Transpose

Software proficiency: MS Office, MS Access

Verbal proficiency: Strong communication skills in English

Laboratory Skills

Have experience in microbiology techniques such as gram staining, serial dilution and media plate streaking.

Proficient with Pipetting and titration.

Making of the microbiological media In House using various ingredients depending upon the recipe

Measuring the ph. of the prepared micro media using the pH meter

Actively involved in the communication of the follow up work in the lab

Efficient with the paperwork done in lab

Education & Credentials

Master of Science in Microbiology May, 2010

Gujarat University, Gujarat, India.

Bachelor of Science in Microbiology April, 2008

Gujarat University, Gujarat, India.

Professional Experience

Abbott, lake county, il, usa. (r & d) January 2015- current

Perform RSCC (Reagent sample carry over Testing) on Architect.

Perform Daily and weekly GMP.

Perform Daily and weekly Maintenance on Architect.

Analysis and Report writing using MS excel, EDMS and Enovator software.

Reviewing and witnessing ELN’S.

Kraft Foods, Glenview, IL, USA. (R & D) February 2014-January 2015

Sr. Microbiologist

Prepare, analyse, and perform the microbiological preparation and testing of Cheese sample.

Read, calculate, record analysis and report results.

Prepare sample for analysis by weighing appropriate amount and diluting to the proper factor and plating the same.

Perform TA and PH monitoring, Gram staining, Pour plating, serial dilution.

Microbiological preparation of creamy buttery (whey & starter) sample for Bacteriophage analysis.

Perform culture growth, culture evaluation, and preservation of the culture.

Medusind Solutions, Gujarat, India Aug/2011-Aug/2013

Content Analyst (Healthcare)

Work with client to aid data request fulfilment

Thoroughly QA and cleanse all dataset

Proficient in product validation

Classification as per UNSPSC

Domain expert in data analysis of hospital and life science data

Worked with multiple projects and can switch easily from one project to another.

Given Training to the junior team, as well as solving queries related to project.

Attribution of life science and medical data by applying the domain knowledge

Proficient in life science related data/products.

Zydus Cadila Health Care LTD, Gujarat, India July/2010-June 2011

Quality control analyst (QC Microbiology lab.)

Bet (bacterial endotoxin test) for finish product, raw material & stability products

Bet validation

Swab analysis

Growth promotion test for microbiology media

Documentation of all above mentioned test

Trained in:

oWater analysis

oWater for injection

oPurified water

oMicrobial limit test(MLT)

Authorized to work in USA

References will be provided up on request.

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