Quality Assurance Development

A S H O K PAT E L

*** ****** ********* ******* *******, Illinois 60169 H 847-***-**** C 847-***-****

*********@*****.***

SUMMARY

A highly accomplished and results-driven operations professional with broadly diverse expertise,

encompassing manufacturing, quality testing, research and development, trouble shooting, process

improvement, training/development, sampling, and scheduling. Utilizes strong operational and

scientific knowledge to mentor other team members and improve efficiency. A dynamic forward

thinker who consistently meets goals while maintaining high standards. An analytical and top-

performing producer who evaluates processes to drive change and to increase production.

EXPERIENCE

ABBOTT LABORATORY, Abbott Park, Illinois

Advance Manufacturing Specialist Oct-2001- Oct-2013

Gained expertise in protein purification, protein binding assays, column work, column pack, cell paste. Proficient in

various complex techniques for Column Chromatography, Sonication, Ultra Filtration, Dialysis, Column Pressure

Packing, Heat and Activation and Aseptic Filtration. Prepare diagnostic assay components including solutions,

bulks, microparticle coatings, probe, plasma re-calcification, calibrator, buffers, tissue Culture and media fills using

GMP/GLP and FDA regulated facilities.

Proficient in common analytical chemistry lab techniques using pH meter, conductivity meter,

spectrophotometer, UV/Vis, titrations including wet chemistry with accurate documentation.

Participated in protocol writing and validation from start to finish prep until document goes in to

production by keeping detail attention.

Performed equipment maintenance, calibration and trouble shooting for all instruments as required.

Reviewed and requested changes for document improvements and document reengineering team.

Completed redlining of manufacturing documents and reviewed them before approval for production.

Maintained expertise for purification and conjugation of Antigen and Antibody with error free

documentation.

Participated with cross-functional team, and the process-support team for CAPA-related investigation

and assist in recognition and resolution of technical or operational problems.

Inspected assigned laboratories to ensure compliance with bio-safety and safety regulations for internal

and external audits.

Participated in safety team discussions to review and relate safety policies, regulations, and practices.

Mentored and trained new employee as Certified On-The-Job Trainer and Subject Matter Expert.

ABBOTT LABORATORY, Abbott Park, Illinois

Advance Product Specialist, Quality Assurance Department March-2000-Oct-2001

Carried out quality testing of in-process samples by performing tests, using SDS-PAGE Electrophoresis, and

Western Blot Analysis. Served as reference designation team member, and held responsibility for assigning and

allocating reference reagent for most codes by approving in timely manner and always keeping available for

testing, giving notice if any issues arose.

QC testing experience in cGMP, OSHA and FDA regulated lab.

Certified in SDS Gel electrophoresis testing.

Review and audit final testing packets for approval.

ADDITIONAL EXPERIENCE

LABORATORY CORPORATION OF AMERICA, Addison, Illinois

Medical Technologist, Chemistry Department 1993-2000

Performed all chemistry profiles and released results within minimum turn-around time frame.

Repeated abnormal samples and followed up with Physician in pleasant and helpful manner.

Executed special tests, such as total Glycohemoglobin (GHb), A1C, and HDL. Completed drug

screenings and released them on time.

Recognized routine operational issues with all instruments and troubleshot.

Maintained, reviewed, and filed all daily, weekly, and monthly control checks.

Mentored team members by sharing operational and scientific knowledge of instruments, as well as

abnormal results.

NATIONAL INSTITUTE OF OCCUPATIONAL HEALTH, (WORLD HEALTH ORGANIZATION),

Ahmedabad, India (Medical and Industrial Toxicology Department)

Research Associate (Medical Technologist 1982-1993

Assisted research officers for method development and validation and held responsibility for perform

testing and trouble shooting on HPLC, GC and submitted all reports to WHO and to the manager.

Coordinated with the scheduler to assign all GMP duties and made schedules for whole department.

Maintained accurate inventory for all chemicals and was responsible for calibration of all instruments for

my department.

E D U C AT I O N

Gujarat University, Ahmedabad, India, B.S., Chemistry, 1980

Bharat Serum and Vaccine, Thane, India, MLT, Medical Laboratory Technology, 1981

TECHNICAL SKILLS

Olympus /AU5200/AU560, Columate II, Varint, Integra (Cobas Roch), Coulter Counter T876,

Helena Electrophoresis. Waters High Performance Liquid Chromatography (HPLC) and (GC)

P R O F E S S I O N A L E D U C AT I O N / C E RT I F I C AT I O N

High Performance liquid Chromatography (HPLC): Fundamentals, Troubleshooting, and method Development

American Chemical Society (ACS) MAY-2013

Gas Chromatography (GC): Fundamentals, Troubleshooting, and method Development

American Chemical Society (ACS) June-2013

Practical Gas Chromatography (GC) by Agilent Technologies, August-2013

Advanced HPLC and UPLC: Rapid Resolution Liquid Chromatography Method Development and

Optimization by Agilent Technology. September-2013

Techniques of High Performance Liquid Chromatography (HPLC) by Agilent Technologies, October-2013

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