Quality Control Service Representative

Nelson Montalvo Rivera

Career

Results oriented licensed chemist with progressive and diversified technical experience in quality control,

Profile

process control, technical services, medical devise and environmental laboratory in demanding fast-paced

2403 Calle Prados Urb. Ext. Valle Alto,

Ponce, P.R. 00730-4147

Day/Night Tel 939-***-****

Email: *********@*****.***

industrial settings. Substantive knowledge of manufacturing operations of oral solid dosage and API products.

Self-starter with demonstrated ability for analyzing data to detect deviations and inconsistencies as well as to

interpret sampling test results. Confirmed expertise in problem solving and root cause analysis methodologies.

In-depth knowledge of specialized laboratory instrumentation. Strong knowledge of relevant cGMPs, GLP,

SOP, LIMS (Empower), Project Management, writing reports and validation protocols cleaning validations,

method transfers and development, Write and execute qualification protocols (IQ,OQ, PQ) based on

established validation procedures, Write and test approvals of Qualification Summary Reports, HAZMAT,

HAZWOPER, NF, FDA, USP, regulations 21 CFR part 11 as well as their application. Proficient in Trackwise,

CAPA, LIMS, and SAP. Major strengths in interpersonal and communication skills establishing and

maintaining positive working relationships with individuals at all levels using negotiation and coaching talents.

Fully bilingual technical writer.

Major Accomplishments

Generated annual cost savings of approximately $10,000 after streamlining EPA methods 524.2,

3695, and 1666 into one method using EPA guidelines and QA criteria reducing total analysis time from

two (2) weeks to three (3) days including full peer reviewed report. Revised method 1666 was adopted

stateside.

Assumed full responsibility for all Environmental Technical Services operations and systems after

company reorganization that involved transfer of two (2) technicians and (2) chemists. Provided accurate

analytical services and equipment troubleshooting uninterruptedly to areas including Quality Control Lab,

In-Process, and Manufacturing Science and Technology Labs on a 24/7 basis.

Lowered concentrations of active ingredients of Zestril and Atenolol in site’s waste water to

comply with Environmental Lab’s Aquatic Exposure Guidelines using Liquid Chromatography Mass

Spectroscopy.

Increased yield in synthesis of active ingredient Dipyradamole from 60% to 75% by establishing

a procedure to recover mother liquors as well as to recrystallize and purify active ingredient increasing

product recovery through experimentation.

Professional Lilly del Caribe, Inc. Guayama, Puerto Rico June 2005 – February 2013

Experience Sr. Environmental Technical Service Representative

Achievements:

Managed Energy Conservation Project, Relocation of the Organic Section analytical

instrumentation from Building 81 to Building 10 in PR06, performed utilities and space requirements,

movement, installation qualifications, operation qualifications, performance qualifications, writing IQ, OQ,

PQ protocols and final validation reports for Analytical Balances Mettler AT200 and AT2610, GC Hewlett

Packard 5890A Series II, HPLC Hewlett Packard 1100 ALS, Agilent 6890 Series GC System, Agilent

6890 GC with Mass Spec 5973N, UV Spectrophotometer Carry 50.

Managed the reduction of annual electricity costs by $60,000 by transferring organic section of

Environmental Technical Services Lab without affecting Solvent Recovery Process, Tank Farm, and

Production Activities.

Managed the identification of gaps between Procedures vs Practices on MFG areas. Created

Process Maps (Flowcharts), Creat Revise SOP procedures and forms. Delivered training to affected

personnel on new documents.

IPR Pharmaceuticals Inc. Guayama, Puerto Rico March 1997- May 2005

April 2001 – May 2005

Environmental Laboratory Supervisor

Nelson Montalvo Rivera, Mobile: 939-***-****; E-mail: *********@*****.*** Page 2 of 2

Achievements:

Managed a $3M budget to purchase equipments, ICP’s, GC/MSD, LCMSD, TOC, LACHAT

IC, Calorimeter, UV/VIS Spectrophotometers, CETAC Mercury Analyzer, Karl Fisher Titrator, and LIMS

(StarLims) by performing FAT’s writing and executing IQ, OQ and PQ protocols and validation reports

also by writing and validating and consolidating analytical methods. Delivering good in time as planned.

Managed the purchased a Mobile Environmental Laboratory (Canovanas Site), made site

assessment for location and installation, performed IQ, OQ, and PQ to Metromh Karl Fisher Apparatus,

Agilent HPLC 1100, pH meters and HACH Field Automatic Auto sampler equipment. Consolidating the

analytical operations of three sites into one.

Distributed environmental analytical sampling and testing ensuring maximum use of resources.

January 1999 – April 2001

Environmental Chemist I

Achievements:

Performed groundwater sampling and analysis by current EPA methods.

Executed development, implementation, revision, regulatory validation, validation protocols, and final

reports of procedures to comply with local and federal regulations.

January 1998 – December 1999

API Chemist I

Achievements:

Maintained general inventory and purchased equipment, reagents, and glassware.

Provided analytical support to other departments.

March 1997 - December 1998

ASG Chemist I

Achievements:

Performed method validations, method transfer, and chemical plant validation as well as other special

tests.

Wrote, implemented, and reported validation protocols, method transfers and troubleshoot analytical

and instrumentation problems.

Pontifical Catholic University of P.R., Ponce, PR Bachelor’s of Science Degree, Major in Chem

Puerto Rico Chemist License No. 2936

Certified QA Analyst, Janssen, Titusville, N.J. Analytical Problem Solving For Chemists, Carolina, PR

ESelected

ducation

Trainings Mass Spectral Interpretation, Somerset, N.J. Problem Solving In the Chemical Laboratories, Guayama, PR

Practical LC/MS, New Orleans, Louisiana Computer Validation, New Orleans, Louisiana

StarLIMS V9-iPR System Training Course, LC/MSD Advanced Applications and Operation, North Carolina

Hollywood, Florida State University, Raleigh, NC.

Professional

Puerto Rico Chemist’s Association American Chemical Society

Associations

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