Quality Control Specialist II

JOSÉ L. MELENDEZ

**** ******** ***** ******: 915-***-****

El Paso, TX 79912 *************@*****.***

SUMMARY OF QUALIFICATIONS

Highly innovative, proactive professional with experience in quality control, quality systems, and regulatory compliance in accordance with national and international regulatory agencies. Possess solid knowledge of quality control laboratory testing such as environmental monitoring, microbiology testing, sterility assurance, and residual analysis with great experience in equipment and process validation for laboratory and manufacturing environments. A self-directed leader with exceptional problem-solving capabilities in constantly evolving situations and outstanding communication and interpersonal skills to quickly establish rapport with colleagues.

Core Competencies:

Regulatory Compliance

Metrology/Calibration

ISO 17025 / 9001 / 10993-7

QA /QC Microbiology Testing

Process Validation

FDA/MHRA/USP/EP

Environmental Monitoring

Equipment Qualification

cGMP / GLP

Laboratory Investigations

Document Control

OOS / NCR/CAPA

Bilingual in English and Spanish

Proficient with Microsoft Office, Industry Specific Software, Laboratory Equipment and Instrumentation

EDUCATION

Bachelor of Science in Chemistry, Minor in Spanish

Texas Wesleyan University, Fort Worth, TX

PROFESSIONAL EXPERIENCE

QUALITY SYSTEM SPECIALIST II, QC MICROBIOLOGY 2015 – Present

BD - Becton Dickinson (previously CareFusion) El Paso, TX

Accountable for performance of quality control microbiological testing compliant with international/national regulations and standards. Partially responsible for overall performance of the laboratory with emphasis on maintenance of laboratory processes and laboratory equipment.

Partial supervision of laboratory testing; environmental monitoring (for air viable, air non-viable, and surface viable, product sterility testing, microbial identification via Gas Chromatography (GC), microbial limit testing, water testing, bioburden testing, and microbial enumeration.

Establish and maintain environmental monitoring program in compliance with ISO and MHRA guidelines.

oEstablished sampling plan, including sampling locations and frequency.

oEstablished the alert/action limits for the controlled environments within the facility.

oAnalyze environmental results and trends and generate quality notifications.

oAdvice and assist in environmental investigations.

Protocol development for process validations of laboratory testing processes such as method suitability for water testing, bioburden testing, sterility testing of product, sterility testing of biological indicators, steam sterilization cycles, and the enumeration of biological indicators and culture suspensions.

Protocol development for validation of laboratory equipment; procedure development and implementation and document changes, compliance with quality system.

Assist in regulatory, customer, and internal audits; assist in troubleshooting efforts and engineering tests; analysis and verification of laboratory results for product release.

Generate non-conformance reports or quality notifications in accordance with established quality control specifications and procedures; preventive maintenance and calibration of laboratory equipment; training of laboratory personnel.

JOSÉ L. MELENDEZ PAGE 2

QUALITY SYSTEM SPECIALIST, QC MICROBIOLOGY 2013 – 2015

CareFusion (now BD) El Paso, TX

Accountable for the performance of quality control microbiological testing in compliance with international/national regulations and standards; Performed laboratory testing such as: microbial limit testing, product sterility testing, water testing, bioburden testing, environmental monitoring, BI sterility testing, growth promotion/ sterility testing of culture mediums, and microbial identification via gas chromatography (GC).

Assisted in troubleshooting efforts and engineering tests; analyze, verified and documented laboratory results; initiate and generate non-conformance reports in accordance with the established specifications and procedures.

Responsible for preventive maintenance and calibration of laboratory equipment; led or assisted in non-conformance investigations.

LABORATORY TECHNICIAN / PRODUCTION SUPERVISOR 2010 – 2013

Dynatec Scientific Laboratories El Paso, TX

Accountable for chemical and microbiological laboratory testing, and responsible for the culture media production and metrology departments for ISO17025 accredited testing laboratory.

Performed laboratory testing such as: Formulation analysis, EtO Residual analysis (GC), sterility testing, water analysis, bioburden testing, environmental monitoring, package integrity, and accelerated aging.

Coordinated and supervised the daily activities in the media production department to ensure team achieved goals and deadlines and maintained quality of final product.

Formulation of culture mediums, laboratory disinfectants, buffered solutions, and other laboratory reagents; training of staff on lab procedures, documentation practices, and safety procedures to ensure compliance with established methodologies, internal SOP's, and cGMP regulations.

Created, revised, and implemented standard operating procedures for chemical, metrology, and other laboratory processes for continuous improvement.

Daily verification of sterilization process, chemical formulations, and pH levels; validated equipment and laboratory systems; delivered weekly and monthly reports to upper management on media formulation/production, and metrology.

Technical resource and support to production processes, equipment malfunction/deviation, and non-compliances; documented lab results, formulation records, production batch records.

Performed quality assurance on all incoming raw materials and laboratory equipment; calibration, verification, and maintenance of laboratory equipment (700+) and supplies for several labs, including chemistry, biology, bacteriology, media production, and environmental.

Traceability documentation for calibrations, verifications, and maintenance of all laboratory equipment; Validations of new equipment and equipment processes; Daily assignation of laboratory event work orders; Ensured laboratory meets environmental testing limits to comply with established standards.

SCIENCE TEACHER 2009 – 2010

Falcon International School Herradura, Costa Rica

Directed Secondary School Department of middle and high school students; supervised staff of eight teachers; ensured student related issues were resolved, grading assessments completed on time, and school supplies purchased as needed.

Taught life science, chemistry, biology, and earth science to general and special needs students in five grade levels; coordinated and assisted with after-school activities such as the science fair, year book staff, soccer team, and Spanish tutoring.

Developed and implemented the curriculum for middle and high school science instruction; monitored, assessed, and documented student work and progress; held parent teacher meetings to ensure parental involvement in student development.

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