1. NelsonRoldánGarcía
Objective To pursue microbiology, chemist or manufactures career on a Pharmaceutical
Industry.
Capabilities Excellent communication skills in Spanish and English. Strong computer systems
analyst. Highly committed, self-driven and determined to successfully fulfill job
requirementswith precision and timeliness.Enjoy challenging situations where mind
and calculating skills are required. Hardworking, punctual and reliable.
Education Universidad Interamericana de PR
Master in Business Administration - Inventory Control Management 2009-2010
BS. Microbiology 1997-2002
Experience
Bristol Myers 2011-present
Manatí
Microbiologist - Laboratory Analyst
Prepare test solutions, compounds, and reagents to conduct test. Operate
laboratory equipment (such as air viable monitoring instruments ; non-viable
monitoring devices for particulate matter analysis, Vitek, Micro-seq or other
similar equipment use for microbial identification; microscopes; Laminar Flow
Hoods and Biosafety Cabinets for the handling of biohazardous material;
autoclaves; glassware washer; ovens; incubators, refrigerators; freezers;
microplate readers; chart recorders, balances and pH meters and other
microbiology laboratory equipment
Generatesenvironmental trends and graphs of the controlled environments, post
then in the manufacturing areasand discuss themwith manufacturing personnel.
Compile and interpret results of tests and analyses. Review documents and
generates the necessary red line document and change requests.
Provide technical support and assistance to clients.
Audit of aseptic techniques and adequate behavior within the controlled
manufacturing environment.
Write technical reports or prepare graphs and charts to document experimental
results.
Perform environmental, viable and non viable monitoring and assist in media
field.
Sample and monitoring plant water system. Documents if necessary inadequate
behavior and generates audit corrective actions if required. Audit the controlled
areas and utilities physical conditions (house-keeping) and generates audit
corrective actions if required.Train the manufacturing personnel in environmental
monitoring sampling and other aseptic processing techniques.
Urb. Interamericana
Calle 28 bloque.AC-6
Trujillo Alto, PR 00976
Telephone: (939) 640-5298
Email:nelson_roldan@hotmail.com
2. Page 2 Nelson Roldán
Maintain laboratory logbooks and worksheets as per cGMP requirements.
Document sample related information/sample custody and results in the
Laboratory Information Management System (LIMS).
Amgen Puerto Rico, Inc. 2010-2011
Juncos,P.R
Associate Quality Control - Sample Management (Kelly)
Execute routine laboratory procedures.
Full knowledge of aseptic aliquot ting and responsible of multiple sample testing.
Perform non-routine lab procedures under close supervision.
Execute sample testing, sample management, standards preparation, and
equipment maintenance.
Perform gas, water, environmental, viable and non viable monitoring.
Prepare complete, accurate, concise laboratory documentation.
Entry the reviews,analysis and communication of results to the computer system.
Perform general lab housekeeping and operate specialized equipment.
Complied with safety guidelines, cGMPs and other applicable regulatory
requirements.
Coordinated and maintained training proficiency.
McNeil Health Care 2008-2010
Las Piedras, P.R
QA Technician Raw material Incoming (Kelly)
Reviews batch records and givesdisposition (approval, rejection, etc.)to the lot or
material produced to ensure that all stepshave been performed and verified where
applicable, that all limits and specifications have been met and the raw materials
and solutions have been tested and released.
Verify that line clearance is performed after manufacturing and packaging
activities.
Identifies basic technical problems and begins to develop problem-solving skills in
consultation with supervisor. Analyzes and interprets study results, investigation in
consultation with the supervisor.
Ensures that all testing and documentation of manufacturing data is complete and
accurate.
Reviews protocols, analytical results and documents associated with
investigations.
Carries out technical and administrative duties as assigned. Authors / reviews
SOPs.
Performthe inventory,the equipment and material,and the equipment calibration.
Sampling of chemical and packaging components.
Operation of IR (infrared) equipment.
Experience in Incoming QA inspection and product disposition in SAP
3. Page 2 Nelson Roldán
Wyeth, Carolina 2007-2008
Carolina, P.R
QC Associate (Kelly)
Responsible for the watermonitoring, environmental monitoring and effectiveness
of the aseptic area.
Performair and surface test.
Assures that line clearances are performed in a timely and effective manner per
establish standard operating procedures.
Experience using Climet and Mas 100 equipment.
Experience in bioburden, Agar stain, compendia and non-compendia test methods.
Execute sample testing, standards preparation reagents,solutions preparation and
testing procedures.
Reviews and edits other documents as required.
Sample management and equipment maintenance.
Lilly del Caribe 2003-2007
Carolina, P.R
Laboratory Technician (Lilly Contractor)
Start Up experience in Biochemistry plant. Expertise in the maintenance system of
the company (MAXIMO) to calibrate and maintenance de equipment and
instrument in the laboratory area. Purchasing laboratory materials and inventory
control.
Generation and correction of DQ, IQ, OQ,PQ, SOP and Final Summary Reports.
Preparation and handling of equipment files. Efficiency in the managing of
document tracking. QC Laboratory Equipment, Health & Safety, Supplies and
Construction readiness.
Microbiology Aseptic Techniques and used of glassware.
Operation of pH Meter, Centrifuges, Conductivity Meter, Micro Centrifuges,
mechanical Pipettes,Digital Pipettes, standard preparation,Analytical and Micro
Balance.
Experience in water and Raw Material assay (Ammonium, Nitrite, Ph,conductivity
and Nitrate Test).
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McNeil 2002-2003
Las piedras,P.R
Granulation operator (Kelly)
Experience in pharmaceutical blending and Granulation,with a sound knowledge
of machines (balances, VG 2000, Glatt, kettle and inverter)operation, and setting
of the equipments.
Perform the duties of operating assigned machinery with materials, load and
unload the product.
Removing finished materials frommachine,and assuring smooth flow of product.
Performvisual and physical checks of in-process and finished materials as per
procedure.
Make entries on paperwork and keep records as required. This will include
mathematical computation where needed.
Performgeneral cleaning of assigned areas where required, keep the areas neat
and observe all safety and health regulations.
Wetzel Pretzel 1999-2002
Carolina, P.R.
Manager Assistant
Maintained efficient operating conditions.
Responsible of the store inventory and purchasing materials
Supervised and trained over 10 employees.
Promoted high office standards and in costumer relations.
Promptly resolved client problems and employee difficulties.
Driven for outstanding sales results.
Reference: Given upon request