Equipment Maintenance Project Process
Resume:
PROFESSIONAL PROFILE.
Experienced supervisor with more than twenty years in laboratory methods and applications in accordance with the organization’s policies following 21 CFR 820, ISO 15197, and ISO 13485. Gain professional growth from laboratory technician to R&D chemistry laboratory supervisor. Extended my experience in the area of chemistry, medical devices development/support, and petrochemistry. Proven great leadership skills by completing many projects before deadlines without compromising accuracy with high levels of responsibilities, managing and leading teams up to seven people. Contend with interviews, training, performance appraisals, recommendations, and disciplinary actions of personnel. Manage laboratory records and documentation for seven years without any external audit findings. Laboratory equipment maintenance/calibration schedules up to date. Looking to obtain a management laboratory position in a dynamic and innovative organization where I can apply my skills and experience to drive success.
Bachelor of Science, B.S. -General Science
Caribbean University, Bayamon, Puerto Rico
EDUCATION
• English
• Spanish
LANGUAGES
SKILLS & ABILITIES
• Strong leadership and supervisory skills.
• More than twenty years’ working in the laboratory environment relating to chemistry/petrochemistry,
and medical device field.
• Ability to motivate subordinates.
• Hazard/Biohazard material handling and disposal.
• Application of Quality and Regulatory
GLP/GMP/GCP guidelines.
• Experience in medical device product development and investigation support.
• Ability to analyze data results.
• CAPA investigations.
• NCR reports.
• Excel, Power Point, Word, Benchmark-Gensuite
COMMUNICATION
• Ability to read, interpret, and present data results.
• Ability to write procedures, reports with
conclusions, and update SOPs’.
LEADERSHIP
• Manage R&D personnel in accordance with the
organization’s policies and applicable regulations.
• Ability to address topics with employees and execute the best solution to resolve problems as needed.
• Open-minded to encourage welcoming,
collaboration and safe workplace.
• R&D representative of the EHS team.
Supervisor, R&D Chemistry
Brenda Camacho
Fort Lauderdale, FL 33312
**********@*****.***
JOB REFERENCES
1. Aaron Ivey-Trividia Health, Inc.
Senior Manager Product Support/R&D
Phone: 786-***-****
2. Janette Lackore- Trividia Health, Inc.
Director R&D
Phone: 954-***-****
3. Daisy Castillo-Trividia Health, Inc.
Quality Engineer II
Phone: 954-***-****
4. Lakecia Stephens-Novo-Dx
Quality and Regulatory Manager
Phone: 954-***-****
CURRICULUM VITAE
Trainings- Compliance Wire Certifications
• Making Ethical Decisions
• Quality System Requirements
• Design Control
• Document Control Production and Process Control
• Nonconforming Product
• Corrective and Preventive Action
• Risk Management for Clinical Devices
• Hazard Communication
R&D Chemistry-Trividia Health, Inc. Fort
Lauderdale, FL / July 2017 – July 2023
Supervisor
Tasks performed:
• Supervise five R&D employees.
• Schedule and lead the execution of the protocols and/or ongoing projects.
• Draft Validation/Verification protocols and reports for new product development and/or existing product.
• Present experimental results and conclusions to management and propose impending steps for the investigation.
• Assist with returned product investigations to find root cause of customer complaint and develop improvement.
• Review records of laboratory equipment maintenance and ensure maintenance/calibration were up to date.
• Schedule equipment calibration with third party contractors as needed.
• Manage biohazard waste and chemical disposal and keep records up to date.
• Laboratory weekly inspection and records via Gensuite.
• Maintain detailed laboratory notebook with ongoing project process, data results and conclusions.
• Interview candidates for new positions and train as needed. Complete performance appraisal, rewards recommendations, and disciplinary actions for existing employees.
• Perform CAPA investigations and completion of NCR reports as needed.
• Participation in the monthly company safety meetings as part of the EHS team. R&D Chemistry-Trividia Health, Inc. Fort
Lauderdale, FL / Sept 2014 – July 2017
Chemist II
Tasks performed:
• Supervise two R&D employees.
• Test of monitoring glucose systems using blood and control solutions.
• Support with human factors Validations.
• Execute stability studies for new and existing products.
• Execute environmental studies for new and existing products.
• Troubleshooting and investigation of product returns.
• Maintain detailed laboratory notebook with ongoing project process and results.
• Training of new employees.
• Assist with lab equipment maintenance /calibration.
• Draft protocols/reports of experimental studies
R&D Chemistry-Trividia Health, Inc. Fort
Lauderdale, FL / Sept 2014 – July 2017
Chemist I
Tasks performed:
• Test of monitoring glucose systems using blood and control solutions.
• Support with human factors Validations.
• Assist with the execution of stability studies for new and existing products.
• Assist with the execution of environmental studies for new and existing products.
• Familiarize with troubleshooting and investigation of product returns.
• Maintain detailed laboratory notebook with ongoing project process and results.
• Assist with lab equipment maintenance /calibration. R&D Chemistry-Trividia Health, Inc.
Fort Lauderdale, FL / May 2006 – Sept 2010
Research Associate
Tasks performed:
• Blood adjustment for product test.
• Maintain detailed laboratory notebook.
• Assist with stability studies removal.
• Keep temp/humidity records of incubators and refrigerators.
• YSI glucose analyzer maintenance.
WORK EXPERIENCE
QC Technician, QC Lab-Trividia Health, Inc.
Lauderdale, FL / May 2002 – Sept 2006
Tasks performed:
• Blood adjustment for product test.
• Preliminary blood test, confirmation blood/control solution test of the final product.
• YSI glucose analyzer maintenance.
• Preparation of buffer.
Lab Technician - BSI Inspectorate
Lauderdale, FL / Aug 1997 – Oct 2002
Tasks performed:
• Quality testing of crude oil, gasoline, diesel, and jet fuel following ASTM, IP, ISO standards.
• Distillations, flashpoint, freezing point, pour point, cloud point, level of metals.
• Laboratory chemical inventory
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