Microbiologist, Quality Control

Nidia Maldonado Mojica

Box ***, Santa Isabel, PR. 00757 939-***-**** ****************@*******.***

Qualifications

Experience professional with more than twenty years within the Quality regulatory industry environment performing as Microbiology laboratory specialist, QA Auditor, QA Technician and QA/QC Lab Analyst. Tasks completed not limited to: Validation and Qualification of the equipment of the laboratory (sterilizers, biohazard hoods”, Celsis); protocol development, execution, final report, Validation of Water systems, Manufacture equipment cleaning & sanitization validation and Swab method validation; analysis of finished product using the Celsis Advance equipment; performed Media culture preparation and sterilization and growth promotion; performed Microorganism isolation, gram stain and identifications. Extended experience in microbiological analysis of finished product, raw material and types of water. Implemented “start up” of the microbiology laboratory and documentation (with minimum supervision). Also, experience in the analytical area, raw material testing, finished product, DI water and the measurements in the metrology area for validation. Other complementary functions within Quality department are: system inspections, documentation review and product release on hand and SAP software system. Skills on planning, coordination, including performing as train the trainer for laboratory personnel.

Professional experience

Nypro Healthcare, Cayey, Puerto Rico 2009- Present

“Validation Quality Technician”

• Performed measurement of medical devices products on validation process (gage R&R, IQ, OQ & PQ) for the engineer department.

• Performed measurements of start-up process and documentation.

• Manage of calipers, micrometers, drop indicator, OGP & optical comparator.

Caribbean Service Validation, Caguas, Puerto Rico 2008 – 2009

“Micro Validation Specialist”

• Performed Swab Validation Method inoculating recovery on 4 different surfaces and holding time for Legacy Pharmaceuticals in Humacao site.

Colgate Palmolive, Guayama, Puerto Rico 1991 - 2007

“Microbiology Laboratory Analyst”

Tasks and Responsibilities not limited to:

• Execute all the established procedures of tests of finished product, raw material and types of water.

• Performed Validation and qualification of the equipment of the laboratory (sterilizers, “biohazard hoods”, Celsis); protocol development, execution, final report.

• Performed Validation of water systems, Manufacture equipment cleaning and sanitization validation.

• Performed analysis of finished product using the Celsis Advance equipment.

• Performed Media culture preparation and sterilization and growth promotion.

• Performed Microorganism isolation, gram stain and identifications.

• Performed Micro Susceptibility Index (MSI) implementation and reports.

• Program the tasks of the laboratory and revision of the documentation.

• In charged of Finished product distribution on the program of SAP.

• Reviewed of internal SOP’s (lab) & formatting the analysis raw data sheets and notebooks.

Nidia Maldonado Mojica Page 2

• Reported the tendencies of the analyses of the laboratory monthly.

• Write up investigations with root cause of the problem and solution.

• In charged of preparing and presenting the micro labs trends North American Division monthly.

Enhancements/ Accomplishments

• Implemented “start-up” of the microbiology laboratory and documentation (with minimum supervision).

• Systematized the sheets of analysis reports and registries, reducing the time of documentation and elimination of papers.

• Presented/display monthly information in plants meeting, instructing to the manufacture employees on the contamination.

• Create a plan of reorganization of the laboratory of microbiology, training and execution of tasks that was in greater efficiency of the laboratory.

• Developed a “backup” of the supervisor of the laboratory of microbiology and quality.

• Systematized and to computerized the program of microbiological susceptibility for the daily use.

Committee members

• Security Committee

• CPR and First Aid Committee

• Internal GMP Audit Committee

• Hazwoper Group

• Control Program Committee

• Pant activities Committee

Allergan Optical, Santa Isabel, Puerto Rico 1985 - 1991

“QA Technician & QA Auditor”

• In charge of analysis of deionized water systems.

• In charge of Media preparation and growth promotion.

• Performed Air Sampling, Sterility Testing.

• Participated in training of the Quality personnel.

• Approved product distribution.

• Performed Inspection of “Incoming” in the warehouse.

• In charge of Finished goods approval for distribution.

• Performed Incoming Inspections of incoming materials.

Enhancements/Accomplishments

• Trained the personnel of the department of “Power” software system, simplifying to the way of inspection and rejection of lenses.

Education

Pontifical Catholic University, Ponce, Puerto Rico

Bachelor Degree in Biology Science

Training

• Good Practices of Manufacture (cGMP).

• “Current Good Documentation Practice” (cGDP).

• “Delivering Quality Excellence”

• Training workshop: Cleaning and sanitation.

• Celsis system training.

• Quality Standards.

• Ebuy.

• Understanding Validation.

Memberships

• Microbiological Society of Puerto Rico

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