Quality Control Technologist Resume Edison, NJ - Hire IT People

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

Bachelor Degree in Microbiology

PROFESSIONAL EXPERIENCE

Oct. 05 - Confidential, 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
I worked on various bench tests, such as testing the product using whole blood, plasma and serum 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 Confidential, 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 Processor

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 Confidential, 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.

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Quality Control Technologist Resume

Edison, NJ

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