Manufacturing Environmental
Resume:
Glenda Rivera
Cellular 787-***-****? 787-***-**** **********@*******.***
Summary of Qualifications
Professional with strong experience in QC laboratories, manufacturing and
technical services areas through Microbiological and Environmental
monitoring tests and data monitoring for Parenterals Pharmaceutical and
solid dosage, manufacturing processes. Experience in laboratory equipments
and instrumentation like: Air Sampling Machines (MAS-100), Analytical
Balances, pH Meters, Climets, Microscopes, Chart Recorders, Incubators,
Refrigerators, Vitex. Working knowledge of GLP, cGMP's, MSDS. Documents
(SOPs / Forms), FDA Regulations, Quality Systems, Aseptic Techniques,
Microbiology Identifications Systems, Environmental Monitoring Programs,
Pharmacopeias (USP, EP and BP), Water System Tests,Environmental Programs,
Validations and Calibration Programs (PQ /IQ/ OQ). Distinguished team
collaborator both as leader and participant contributing significantly
demonstrating strong values, respect and professional ethics. Knowledge on
computer skills in Microsoft Office (Word, Excel, Outlook and Power Point),
Internet, GxPharma -Webcache, SAP, LW/LIMS, LACES, and Citrix . Bilingual
English and Spanish.
Professional Experience
Mc Neil, Las Pierdas
2013 to present
Microbiology (Contractor)
. Be part of the work plan (QSE), responsible for establishing robust
methods and processes for regulatory agencies.
. Evaluating and proposing methods to improve the laboratory process and
procedure.
. Document and verify the microbiology data analysis.
. Ensure compliance with regulation guidance in the creation, execution
and reporting of validation protocol.
. Review documents that were included as part of Microbiological Method
Validation Protocol.
. Execute Protocol (Suitability, Methods and equipment.)
. Execute water Sampling and Analysis (Purified Water, Potable and Pre
Treatment).
. Evaluating and proposing methods to improve the laboratory process and
procedure.
. Execute water sampling and analysis (Purified Water, Potable and Pre
treatment).
. ID analysis (Gram stain).
Accomplishment
. Work in a pharmaceutical environment in consent decree.
Pfizer Pharmaceuticals, Guayama,Puerto Rico
Microbiologist 2013-2010
. Monitored for manufacture new facilities.
. Supported and prepared Protocol for Start-up and annual environmental
monitoring for new facilities Environmental Project sample ID
environmental test (Gram, Vitek,) and supplementary test, Coagulase
and Oxidase, Sampling, testing and disposition of microbial samples.
. Performed identification of organisms recovered from microbial samples
using manual and automated systems.
. Prepared culture media, perform culture media QC test, and maintain
appropriate inventory, performed growth promotion testing and
sterility.
. Tested water samples, raw materials, products and stability samples.
. Collected environmental samples according to the environmental
monitoring program (Environmental air and equipment cleaning).
. Processed reported and audited Data ID Area. Data review according to
establish procedure and disposition of microbial samples using LIMS.
Accomplishment
. All the PQ, IQ and OQ were conducted and reported according
validations plans.
. To have been employed at a plant under 483.
Amgen Pharmaceutical, Juncos, Puerto Rico
2009 - 2010
. Monitored for manufacture new facilities.
. Supported and prepared Protocol for Start-up and annual environmental
monitoring for new facilities Environmental, testing and disposition
of microbial samples.
. Collected water samples and tested.
. Collected environmental samples according to the environmental
monitoring program (Environmental air and surfaces Viable Particle,
Non-Viable Particle).
Accomplishments
. Ensured that protocol test requirements meet the acceptance criteria
and that systems and their corresponding documentation were completed
and organized in compliance with current Good Manufacturing Practices
(cGMP).
Wyeth Pharmaceuticals, Guayama,Puerto Rico
Microbiologist 2006-2008
. Monitored for manufacture new facilities.
. Supported and prepared Protocol for Start-up and annual environmental
monitoring for new facilities Environmental Project sample ID
environmental test (Gram, Vitek,) and supplementary test, Coagulase
and Oxidase, Sampling, testing and disposition of microbial samples.
. Performed identification of organisms recovered from microbial samples
using manual and automated systems.
. Prepared culture media, perform culture media QC test, and maintain
appropriate inventory, performed growth promotion testing and
sterility.
. Tested water samples, raw materials, products and stability samples.
. Collected environmental samples according to the environmental
monitoring program (Environmental air and equipment cleaning).
. Processed reported and audited Data ID Area. Data review according to
establish procedure and disposition of microbial samples using LIMS.
Accomplishment
. All the PQ, IQ and OQ were conducted and reported according
validations plans.
Glaxo Smith Kline, Cidra PR.
2005-2006
. Ensured of the Quality Standards Parameters to perform a
microbiological testing, environmental, as well as: microbial load,
surface, air, viable particles, the particles non viable
. Sampling and Analysis of water.
. Cold System Water Validation.
Accomplishments
. Worked in an industry under a consent decree.
. Met in time with the projects assigned by the supervisor.
Wyeth Pharmaceutical, Guayama PR.
2004-2005
. Worked with GMP
. Raw Material weighting according to the charter of manufacturing using
SAP and MES.
Accomplishments
. As a pharmacy operator, I had the experience with a manufacturing
letter that had an error with the active ingredient. As a result of
this error the loss prevention of lots was accomplished.
. Compliance with current Good Manufacturing Practices (cGMP).
Education
Inter American University, Ponce Campus, Puerto Rico
2005
Bachelor Degree in Microbiology
Trainings / Certifications
Analyst Certification
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