Quality Control Years Experience

Deepali S. Purohit

****, ********** ****, *********, **-24502 ( Email: ********@*****.***

OBJECTIVE To attain a challenging position in the field of science, which

will allow me to utilize my experience and leadership in

the field of Science.

EDUCATION Citton Institute, Edison, NJ.

Diploma in Computer Science

1998

Laboratory of Dr. Toparani, India

Diploma in Medical Laboratory Technologist

1995 - 1997

M B Patel Science College, India

Bachelor Degree in Microbiology

1990 - 1995

PROFESSIONAL EXPERIENCE

Oct. 05 - Present International Technidyne Corporation Medical,

Edison, NJ

Quality Control Technologist II

. Perform and coordinate stability testing for

method/product/process validations on both legacy

products and those in development; document and

maintain results, prepare and publish reports.

. Investigate Out of Specification (OOS) results; prepare

and publish OOS report for non conforming stability

products.

. Responsible for the execution of a broad range of bench

test procedures used in raw material qualification,

testing of finished goods prior to release, the

investigations of product performance and conducting

various validation studies.

. Reviewing and releasing batch records according to SOPs

and in compliance to FDA-GMP/QSR and ISO standards for

quality.

. Work with QC/QA staff to resolve product performance

issues and maintenance of the documentation files of

approved QC Standard Operating Procedures in compliance

with ISO EN 46001:9001 and ISO EN13485 standards.

. Undertake special in-process projects such as Microbial

studies (In conjunction with Gibraltar labs),

characterization, stress tests, validation and VRPs,

according to SOP.

. In charge of QC's current real time stability and

accelerated stability evaluation process with ISO EN

13640:2002 of In Vitro Diagnostic Reagents, in-coming

raw materials and control plasma

. Streamlining current SOPs to reflect changes and

writing of SOPs for new bench testing procedures.

. Actively involved with various projects such as

validation of in-coming raw materials, characterization

of raw materials, new test methods and qualification of

in-coming raw materials and control samples.

. Training new employees and assisting other departments

when needed.

April 04 - Oct. 05 Quest Diagnostics Inc., Summit, NJ

Lab Assistant

. Performed tests and analyzed according to established

testing procedures and maintained complete records of

all testing performed in designated technical

department.

. Followed the laboratory's procedures for specimen

handing and processing, test analyses, reporting and

maintaining records of patient test results.

. Reviewed and released test results.

. Followed department's procedure in reporting STATS or

Critical results to clients.

. Make sure reagent/test kits have received dates,

expiration dates, and if applicable opened dates.

Responsible for operating, maintaining and calibrating the

equipment such as a Coulter LH automation line for

Hematology, ACL for coagulation used to ensure that it is

operating efficiently and providing accurate results.

Participated in all applicable safety training sessions. Know

the location/use of all applicable safety equipment.

Jan. 01 - Nov. 03 Laboratory Corporation of America, Raritan, NJ

Specimen Accessioner

Unpack specimens from braches and routes with type to various

staging areas.

Prepared laboratory specimens for designated departments prior

to lab analysis and testing.

Prepared all specimens and aliquots (Serum and Urine) received

for testing in designated departments such as staging of

specimens, centrifuge, separation of serum and blood smears

and freeze specimens as required by test order.

Prepared excess specimen samples for storage and resolved the

documents of problem specimens.

Prepared reagents and controls using automated or fixed volume

measuring devices according to established guidelines.

Entered data accurately into the computer system by manual or

electronic methods and placed specimen in the appropriate

test code rack, in the appropriate position of the rack and

the correct rack ID.

Delivered specimen to appropriate departments with care and

maintained the confidentiality of client information.

Submit documentation to appropriate staff for approval to use.

Promptly and courteously answers phones, transfers or takes

accurate messages

Aug. 99 - July 01 Aculabs Inc., Edison, NJ

Phlebotomist

Performed daily phlebotomy activities at several Patient Service

Centers and ensured that specimens are collected accurately

and on time.

Blood collected by venipuncture and capillary technique from

patients of all age groups, urine drug screen collections.

Performed related duties such as, data entry, filing, ordering

stock supplies, aiding coworkers as needed, answering the

telephone in a friendly and professional manner and

maintaining required records and documentation. .

SKILLS

Seven years experience as a graduate in Microbiology with

in-depth knowledge in pathological laboratory procedures

and equipments.

Proven capability in practical experience, educational

background and integrated hospital record keeping.

LABORATORY

Precision Pipetting, operation of micro centrifuge,

fibrometers, Coulter LH, Sysmex CA-560 or CA-1500,

computerized vision systems, integra-700 and ACL 8000

units.

COMPUTER

Proficient in Microsoft Office, JDE System, Microsoft

Windows, Office, Excel, & PowerPoint.

OTHER

Knowledgeable in cGMP, and GLP, ISO and FDA regulations.

REFERENCES

Personal and Professional reference will be furnished upon

request.

Contact this candidate