Project Manager Supervisor

Mailing Address: **** Rockville Pike, Bethesda, MD, 20889

Tel. (301) 300- 4854 ******.******@*****.***

SUMMARY OF QUALIFICATIONS

Dynamic Quality Control Microbiologist with over six years of experienced

in Pharmaceutical Industry with outstanding knowledge in GLP's, SOP's,

GMP's, OSHA, ISO, aseptic techniques, EPA and FDA regulations aligned with

the company, vision, mission and share values. Hardworking, organized, team

leader, clear thinker and able to performed multi-step procedures. Computer

Literate, Windows XP, Microsoft Project Manager, Microsoft Office, WORD,

Power Point, EXCEL, LIMS, spreadsheet, graphic and Lab Manager. Outstanding

Oral and Writing communication. Bilingual in English and Spanish. 55 words

per minute.

ACCOMPLISHMENTS

. Reduce the cycle time of a sample to be analyzed.

. Reduce documentation error for a 30% (Kaisen).

. Advise new ideas, techniques and methods to solve complex analytical

problems in a more cost-effective way.

. Redesigned the workflow through out and providing more workspace in the

laboratory.

. Certified to train new employees in all fields.

. Knowledge of Federal Regulatory Compliance.

PROFESSIONAL EXPERIENCE

Aveva Drug Delivery System, Inc. 03/2011 - 11/2011

Miramar, FL United States

Microbiologist/Analyst II

Supervisor: Brando Grillet 954-***-****)

Okay to contact this Supervisor: Yes

. Responsible to prepare samples for analysis, including water, raw

materials and air samples.

. Perform Microbial Limits and Microbial Limits Validation assay of

finished products, raw materials, and components in a timely manner.

. Routine sampling and testing of the USP Purified Water System by the

filtration technique or/and by pour plate method, according to the USP/EP

Pharmacopoeia.

. Perform bio-burden monitoring of the manufacturing facility and the

microbiology laboratory.

. Perform on-site surveys to identify environmental deficiencies and

provides technical advice.

. Perform and review studies designed to prove the product quality.

. Review current USP and the regulatory guidance to ensure compliance with

current microbiological methods and practices.

. Responsible for daily monitoring and testing of the USP Purified Water

System.

. Author, and review of microbiology Protocols, Reports, STP's and SOP's.

. Responsible for microbiology testing for weekend and holiday schedules,

as needed.

. Analyze, determine adequacy of data and perform trend analysis of

microbiology test results from products, water system, bio-burden and

author reports.

. Perform PQ on instruments and author the protocols/reports.

. Attend seminars on special topics to continually evaluate improvements to

the microbiology laboratory, testing, and policy.

. Participate in audits and/or consultations with other departments, as

required.

. General procurement assignments and responsibilities for the microbiology

laboratory: monitor housekeeping, bio hazard waste disposal, sample

discard, discard of expired reagents, media preparation, sterilization of

waste and glassware, instrument calibration/maintenance/daily monitoring,

quarterly expenses report, and inventory/ordering.

. Ability to communicate both orally and in writing results, techniques and

status of projects.

. Document equipment maintenance.

. Keep laboratory equipment and materials inventory updated.

Pfizer Pharmaceuticals LLC 05/2003 - 11/2009

Vega Baja, PR United States Hours per week: 40

Microbiologist

Supervisor: Wigberto Gonzalez (787-***-****)

Okay to contact this Supervisor: Yes

. Responsible to prepare samples for analysis, including water, raw

materials and air samples.

. Elaborated, coordinate and executed validation protocols as well as

manufacturing validation support.

. Equipment validation such as autoclave, microwave and incubator.

. Performed Laboratory audit to guarantee compliance and safety.

. Monitored activities to assure the best analysis in a more cost-effective

way.

. Data revision and SOP's revision for the laboratory area.

. Implemented new FDA's regulations (harmonized).

. Routine sampling and testing of the USP Purified Water System by the

filtration technique or/and by pour plate method, according to the USP/EP

Pharmacopoeia.

. Sampled and environmental monitoring using either the Rodac, Swab and RCS

method.

. Analyzed Material (finish product, raw material and process) according to

the USP/EP Pharmacopoeia.

. Knowledge of the Limulus Amebocyte Lysate (LAL) test for detection and

quantitative of bacterial endotoxin.

. Perform on-site surveys to identify environmental deficiencies and safety

deficiencies and provides technical advice on how to improve and prevent

the identified deficiencies.

. Developed new techniques and procedures to meet with regulations as well

as to permit the maximization of in-house testing.

. Identified microorganism using the API technique, gram stain and by using

the VITEK.

. Experience working with in a biosafety level 3 laboratory.

. Leads laboratory investigations for out of specification microbiological

testing results.

. Provides corrective action and recommend process improvements.

. Knowledgeable in the use and maintenance of the Aqualab Water Activity

Meter, MicroStar and Celsis equipments.

. Used and maintenance of the autoclaves.

. Analyzed data and accuracy of the sterilization method used.

. Prepared and growth promotion of the media used for analysis.

. Inventory of the materials, media in use, dehydrated media (stock) and

microorganism on stock (stock culture).

. Water, Environmental and Material trend analysis.

. Knowledge of the procedures and equipments use in the manufacturing area.

. Responsible for the microbiology laboratory safety meeting (monthly).

. Responsible for the disposal of contaminated materials, according with

the disposal regulations.

. Ensured availability of all supplies requires for microbiological

testing.

. Performed data analysis, summaries of collected data and submit

recommendations and conclusions to others departments.

. Responsible for the water, environmental and water trend analysis.

. Skills to communicate and explained out of specification reports and

trend analysis to managers.

. Authorized to train new employees or for re-qualifications.

Puerto Rico Louis Stokes Alliance of Minority Participation, Arecibo, PR

2002 - 2003

Undergraduate Research Assistant

Supervisor: Professor Arbelo

Investigation: Project Title: Absorption of Lead (Pb) by the roots of the

aquatic plan Eichhornia crassipes (water hyacinth)

Responsible to identify areas such as the leave and root, were the plants

used to retains the most quantity of lead (Pb) and how these plants

transform the lead (Pb) into something less hazardous. Helping to maintain

and purify the water so in the future they can be used as water purifiers.

. Develop and execute high quality scientific research.

. Microbiological analysis; viable and non-viable.

. Identification of microorganisms.

. Environmental Monitoring.

. Maintain accurate records and documentation of all test results.

. Propose process improvements.

. Method development according to the data generated.

. Preparation of culture mediums.

. Excellent aseptic techniques.

. Prepares weekly and monthly reports with excellent documentation skills.

. Improve the analysis and implement new techniques.

. Order laboratory supplies.

. Responsible to communicate results and out of specification results to

supervisors.

EDUCATION

University of Maryland University College, Adelphi, MD

M.S. Science Biotechnology

University of Puerto Rico, Arecibo, PR

B.S. in Biology; major in Microbiology

Graduated Cum Laude

Colegio Nuestra Se ora del Carmen, Hatillo, P.R.

General Education

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