Technician Laboratory

Amarilys Chacon

**Yorkshire circle Ewing NJ *****

(787) 391 - 2774 / acco4k@r.postjobfree.com

Summary of Qualifications

Scientist with 11 years of experience in the pharmaceutical industry,

manufacturing environment. Knowledge in laboratory standard procedures,

laboratory safety, cGMP's, and IOP. LACTP (Laboratory Analyst Training and

Certification Program). Experience using laboratory equipment such as:

HPLC, UPLC, GC, Water bath dissolution, pH meters, UV, IR, Melting Point,

Viscometer, Karl Fisher and Polarimeter. Troubleshooting instrumentation

when its necessary. Empower2, LIMS and Trackwise knowledge. Experience

performing testing for Bulk(API), Semisolid and solid finished products.

Bilingual (English & Spanish). Willing to work irregular program schedules.

Professional Experience

Janssen Pharmaceutical, Titusville, NJ 2010- to present

Analyst II, Stability Laboratory (Kelly OCG contractor)

Laboratory analysis by HPLC and Dissolution Instrumentation on stability

samples. Maintain an accurate laboratory notebook which includes sample

data for all tests performed. Perform daily calibrations and routine

maintenance on laboratory instrumentation and equipment according to

current SOPs. Assist in various other duties that contribute to the

organization and function of the laboratory. Serve as a technical trainer

for other associates. Maintain a high level of awareness for GMP.

Selected Achievements:

o Kelly personnel lead

o Performed Method transfer

2004- 2009

Ortho Pharmaceutical, Manat , PR

Scientist I, Finished Product Laboratory

Responsible for performing chemical and physical analysis of solid and

semisolid pharmaceutical products in accordance with company's

specifications and Compendia requirements. Responsible for following

Laboratory trigger and In-process board to support manufacturing rhythm

wheels and business rules. Generate investigations of non-conformance

product. Perform internal audits to ensure GMP compliance. Integrated the

2008 Annual Product Review team to verify monthly product compliance with

specifications.

Selected Achievements:

o Worked in Standard Stability project for solid products (tablet).

o Employee of the Month in 2006.

SCHERING PLOUGH, Manat , PR

Analytical Technician II, Technology Transfer Laboratory 2000 - 2004

(2001 - 2004)

Performed Assay testing for Drug Substance and finished products. Conducted

and revised laboratory deviations/investigations. Performed and generated

Change Request plan for SOP. Audited laboratory logbook and testing data.

Followed SOP's and approved methods under FDA regulations.

Selected Achievements:

o Participated in method transfer activities for SP-New Jersey.

o Integrated the QC Laboratory set up for FDA audit and performed

method transfer using GC and HPLC.

o Executed method transfer in an external company which developed

methods for Schering.

Analytical Technician I, In Process Laboratory (2000 - 2001)

Performed physical and chemical analysis of drug substances.

PFIZER PHARMACEUTICAL, Barceloneta, PR 2000

Analytical technician I, Organic Synthesis Laboratory

Performed physical and chemical analysis of raw materials and bulks.

Education

Polytechnical University of PR: MS Manufacturing Process

University of PR Humacao Campus: BS Industrial Chemistry

University of PR Aguadilla Campus: AD Natural Sciences

Trainings & Workshops

Lean Six Sigma . Train the Trainer . Millennium 32 Integration

Alliance HPLC System Performance Maintenance & Troubleshooting

Waters 2695 Separation Module . 5S-A Foundation for Improvements

Notice of Event (NOE) . Deviation Investigation Report (DIR)

CAPA Procedures . Kepner Tregoe Problem Solving Workshop

Effective Meeting Skills . Back to the Lab Basic . Root Cause Analysis

Consent Decree and Deviation Investigation Importance

Effective Technical Writing . Conducting and Writing Investigations

Fundamentals of Capillary GC . Column Selection and Troubleshooting

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