Wandaly Márquez Colón
Juana Díaz
Summary
Experienced Microbiologist with proven experience improving scientific community by performing accurate research while complying with laboratory safety protocol and standards. Outstanding data management and report development skills contributing to research funding efforts. Seeking a QA Lab Team Leader position.
Overview
14
14
years of professional experience
Work History
Microbiologist Sterilization II
Medtronic
01.2018 - Current
- Interpreted research findings and summarized data into reports.
- Ordered laboratory equipment and supplies to maintain inventory.
- Coordinate, lead and support validation activities for Annual Sterilization re-qualifications including physical performance qualification and microbial performance qualification.
- Evaluation of Sterilization equipment Repairs.
- Perform the evaluation and disposition of manufacturing product involved in sterilization failures. Analysis of Sterilization Equivalence program.
- Perform risk assessment to determine the clean room risk zones, based on criticality of the different manufacturing process.
- Assumed the interim laboratory leader role during the supervisor absence. Prepare the schedule for the routine laboratory tasks distribution, coordinate special tests and projects distribution.
- Participate in Site leaders meeting providing status of sterilization validation activities.
- Lead and perform sterilization and endotoxin failures investigations.
- Analysis and trending of laboratory and sterilization data in Minitab Statistical Software.
- Qualification activities of new products.
- Perform failure modes and effects analysis of causes and possible mitigations for biocontrol and endotoxin.
- Support in CAPA investigations and actions.
Microbiologist Sterilization Associate
Medtronic
01.2013 - 01.2018
- Environmental monitoring of surfaces and air in controlled environment areas.
- Bioburden testing of devices including leads and accessories.
- Gel Cloth Method, Chromogenic and Turbidimetric Endotoxin tests of DI Water and manufacturing products.
- Release of manufacturing products.
- Bacterial water analysis testing to DI Water, gowning water and Isopropyl Alcohol.
- Macroscopic and microscopic characterization of microorganism and gram staining techniques.
- Buffers preparation.
- Parametric release of products sterilized with 100% EtO.
- Investigation and evaluation of out of specifications testing results.
- Support sterilization, manufacturing and laboratory areas.
- Evaluation and disposition of manufacturing product involved in sterilization issues.
- Evaluation of annual validations of sterilizer and aerators chambers.
- Perform requalification reports of sterilizers systems.
- Update sterilization certifications of manufacturing products.
- Writes plans and reports related to laboratory and sterilization area.
- Updates procedures and documents related to sterilization and microbiology.
- Maintain laboratory trends of testing results.
- Create and evaluate non-conformance.
Quality Technician
Medtronic
01.2010 - 01.2013
- Monitoring of surfaces and air in clean room environment.
- Bioburden of leads and accessories.
- Automated Pyrogen test of water and product.
- Bacterial water analysis to DI Water and gowning water.
- Macroscopic and microscopic characterization of microorganism.
- Gram staining techniques.
- Good documentation practices and maintaining aseptic techniques.
- Parametric release of products sterilized with 100% EtO.
Education
Bachelor of Science - Industrial Microbiology
University of Puerto Rico
Mayagüez05.2008
Skills
- Work effectively as a team leader, member or individually
- Excellent Written and Verbal Communication
- Fast learner and results oriented
- Excellent laboratory skills
- Good documentation accordance with cGMP's
- Handle effectively laboratory equipment and maintaining aseptic techniques
- Work effectively in computer programs like Microsoft Word, Power Point and Excel
- Ability to perform trending in Minitab program
- Training in Lean Sigma
- Maintain knowledge in sterilization and microbiology standards
- Ability to prepare plans and protocols
- Advanced Mathematical Abilities
Timeline
Microbiologist Sterilization II
Medtronic
01.2018 - Current
Microbiologist Sterilization Associate
Medtronic
01.2013 - 01.2018
Quality Technician
Medtronic
01.2010 - 01.2013
Bachelor of Science - Industrial Microbiology
University of Puerto Rico
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