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Chemist Assurance Auditor

Location:
West Orange, NJ, 07052
Posted:
October 25, 2022

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Resume:

ENKELEDA GASHI

** ******* ****, *********, **

973-***-**** ● ads6sz@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Quality Control / Assurance Supervisor, analytical chemist performed qualitative and quantitative analysis on pharmaceutical and consumer goods industries. Worked with c- GMP, GLP, DEA, OSHA, USP and FDA regulations. Well versed in ISO 9000 and familiar with NJ State Environmental Department of Protection rules and regulations. Can work in a team as well as independently.

PROFESSIONAL HISTORY

BARR LABROATORIES, East Hanover, NJ Nov,2006 - April,2009

Chemist II

Performed analytical tests for release, validation batches and stability studies. Worked with suspensions and solid dosage.

Arranged, assigned schedule tests for maximum efficiency, in turn improving release to next stage of testing process.

Pfizer / Adecco

Chemist

Completed training program within timely manner. Sept,2006 - Nov,2006

HOFFMANN LA ROCHE/ Aerotek, Nutley, NJ 2005 - 2006

Chemist

Worked in Analytical R&D Department. Performed analytical activities for drug substance and dosage forms at discovery. Participated in discovery and development team activities to ensure timely support of clinical studies on new pharmaceutical products using UV, HPLC Agilent1100. Analyzed stability samples. Documented in notebook and LIMS. Checked other chemist's notebooks for compliance.

Strong ability to take initiative and find creative solutions.

ABBOTT LABORATORIES/ MANPOWER, Whippany, NJ 2005 – 2005

Chemist

Performed analytical tests on release, stability, and validation for solid dosage. Planned assigned work and completed tasks within required time frames.

LTS CORPORATION/ SYRNAFAC, West Caldwell, NJ 2004 – 2005

Chemist

Worked with Second Class Controlled Substance, nicotine, for release, method transfer, validation and cleaning validations for transdermal patches. Performed Content uniformity, Assay, Release rate, ID Tests using HPLC system Total Chrome software.

ABBOTT LABS/ MANPOWER, Whippany, NJ 2003 – 2004

Chemist

Performed dissolution tests for stability studies on solid dosage.

UNIFOIL, Fairfield, NJ 2001 – 2003

Supervisor, Quality Control/ Assurance

Supervised three employees on two shifts. Conducted laboratory investigations as needed. Monitored all manufacturing areas for good manufacture product compliance.

Worked directly with R&D to establish procedural manual currently used as reference guide for all QA tests on finished products.

Organized and formatted data in excel to support easy analysis and detection of product related trends for ISO 9000.

Planned and distributed departmental work based on daily production schedule.

EDUCATION AND PROFESSIONAL DEVELOPMENT

B.S., Biology and Chemistry, UNIVERSITY OF TIRANA, Tirana, Albania. WES Evaluation upon request.



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