Febel Figueroa
Coral Springs,USA
Summary
Experienced microbiologist with a proven track record in enhancing the scientific community through accurate research and strict adherence to laboratory safety protocols and standards. Demonstrates expertise in data management and report development, leading to successful contributions to quality efforts.
Overview
9
9
years of professional experience
1
1
Certification
Work History
QC Microbiologist II
SKNV or Sincerus Pharmaceutical
Fort Lauderdale, USA
02.2023 - Current
- Perform Quality Control (QC) testing of samples including, but not limited to, bioburden, sterility testing, growth promotion, method suitability, USP 60,61,62.
- Microbiological detection through the use rapid microbial test Soleris Next Generation (Neogen)
- Review test results and manage Biomaterial Tracking System (BTM) according to internal standard procedures to ensure proper management, tracking, and disposition
- Collect Environmental Monitoring samples of the facility, documenting and reporting results
- Maintain proper documentation and trend analysis of QC test results
- Track equipment calibration and maintenance records
- Perform laboratory cleaning and maintenance of equipment as needed
- Support and execute qualification/validation protocols of QC testing methods as applicable
- Review testing reports, protocols, and procedures to ensure compliance with internal requirements and applicable regulations
- Maintaining the laboratory stock of media and reagents and ordering laboratory supplies
- Setting a new laboratory with all instruments
- Perform training of current and new employees
- Performed IQPQ in different equipments (TCI units, BSC, Colony counter, purified water system
- Oversees daily operation of Microbiology laboratory regarding routine process, reviewing work assignments, establishing priorities
- Streamlined documentation processes which resulted in increased productivity and reduced errors.
- Actively participated in external proficiency testing programs which helped validate laboratory competency.
- Assisted in continuous improvement initiatives by identifying areas of concern within the QC Microbiology department.
- Collaborated with cross-functional teams to address product quality issues related to microbiology.
- Maintained strong working relationships with suppliers to ensure timely delivery of critical reagents and consumables needed for testing purposes.
QC Microbiologist
New Vision Pharmaceuticals
Tamarac, USA
01.2019 - 02.2023
- Responsible for performing routine microbiological testing in a pharmaceutical/nutraceutical manufacturing facility
- The QC Microbiologist will continue to assure that Microbiology Lab operations and testing are performed in compliance with applicable regulations, company specifications, procedures/policies and current industry practices
- Will implement standard analytical methods and documentation, as well as manage lab supplies and inventory
- Maintain proficiency in all Microbiology laboratory methods, processes, and procedures
- Training incoming analysts and technicians on methodology
- Track inventory of supplies and reagents to ensure no interruption of work-flow
- Perform method validations or verifications with minimal supervision as needed
- Understands and complies with cGMP standards, SOPs, Environmental Health & Safety, and Quality requirements and applicable regulations
- Performs sampling and testing as required for environmental monitoring personnel monitoring, sampling of raw materials, in-process product, and finished product
- Performs sampling and testing as required for monitoring of critical systems; Purified Water, Water for injection, City water, Pure Steam, Compressed Air (point of use and blow fill seal, etc
- Support in aseptic process: sterile gowning sampling, air sampling, EM in different conditions static and dynamic, nova septum's sampling and intervention in media fill process
- Prepares testing, solutions, media, cultures, and reagents as required
- Documents reviews, evaluate reports, and archives analytical results
- Maintains laboratory Logbooks as detailed in applicable procedures
- Produces periodic reports for tracking, evaluation of trends, etc
- Performs calibration checks of instrumentation and devices such as, but not limited to RCS unit(viable), Met one (particles count-non viable) and Pinocchio
- Performs testing in support of product development projects, investigations, and monitoring of utilities systems
- Performs testing in support validation department (validation process and cleaning validation)
- Provide scientific interpretation of results to supervisors, management or customers as requested
- Use of Biological indicators in support of cleaning validation process
- Experience with the sampling of TOC and Conductivity
- Performs different test growth promotion, Bioburden, microbiological identification (Vitek), Bacterial Endotoxin Test
Quality Control Inspector
IQ Formulations, LLC
Tamarac, USA
04.2018 - 11.2018
- Check for conformance to the established specification for in process and finished goods in manufacturing and packaging
- Document all activity at the time of performance following Good Documentation Practices
- Submit finish product samples to Quality Control Chemistry laboratory for analysis
- Assist in the maintenance of the rejected materials storage areas
- Perform room or equipment clearance inspections for production and packaging areas for startup
- Review cleaning logbooks daily
- Perform swabs
- Obtain labeling materials upon request of the Packaging Department
- Verify labeling materials for use in Packaging
- Ensures that balances are reviewed and calibrated
- Check counts, weight variation, physical appearance for products throughout the packaging process
- Verify that packaged product corresponds with requirements as stated on the packaging batch record
- Obtain samples of finished products to be help as retainers
- Collect and submit finished product samples as required by packaging masters and specifications
- Perform released of room in the manufacturing process
- Perform AQL inspections per written instructions
- Apply release stamp as appropriate to release components
- Report discrepancies and issues to Team Leads or QA Manager
- Apply rejected stickers to materials as instructed
- Assure that rejected materials are transferred to the appropriate areas for further processing
QC Microbiologist I
International Medical Industries
Pompano Beach, USA
02.2016 - 04.2018
- Enhanced laboratory efficiency by streamlining sample processing and implementing new testing procedures
- Reduced contamination risk by maintaining a sterile laboratory environment and adhering to safety protocols
- Increased accuracy of test results through meticulous attention to details during data analysis and interpretation
- Supported research projects with timely specimen collection, preparation and documentation
- CGMP practices in documentation and execution of job functions
- Fulfill request from management for assistance in other matters as needed
- Participate in daily and monthly meetings
- Performing inventory as needed
- Performing growth promotion testing on media
- Performing Environmental Monitoring within the controlled manufacturing areas and QC laboratory with different ISO class, in accordance with approved SOPs
- Assist with generation of data Environmental Monitoring and trending report as needed
- Participate in generation of alert and action level documentation
Education
Bachelor of Science - Medical Laboratory Technologist or Medical Laboratory Scientist
University of Carabobo
Bachelor of Science - High school diploma
Romulo Gallegos
Clinical Laboratory Scientist -
American Medical Technologist (AMT)
01.2019
Skills
- Microsoft Office
- Fishbowl Management Software, ERP Systems,Barcode software
- Time management skills
- Attention to detail
- Teamwork
- Laboratory safety protocols
- Collaborative Teamwork
- Task Prioritization
- Decision-Making
- Data Interpretation
- ELISA Assay
- Microbial Identification
- Environmental Monitoring
- Gram Staining
- Sterility Testing
- Bioburden Testing
- Endotoxin Testing
- Media Fill Process
Certification
Current and Valid State Florida License, Department of Health, Division of Medical Quality Assurance.
Qualifications : Microbiology , Serology, Immunohematology, Hematology, Chemistry.
Active
Additional Information
RCS, Trio Bas Duo, MetOne, Vitek , Pinocchio II , Sphere Flash Colony Counter, Soleris Next Generation , pH Metter Seven Excellence. Milliflex Oasis Filtration System, Sartorius Air Sampler _ Gelatin Membrane Filters, Endotoxin Test Charles River.
Personal Information
Authorized To Work: US
Awards
Employee of the Year, 12/2017, International Medical Industries
Affiliations
- American Medical Technologist (AMT)
- American Society for Clinical Pathology (ASCP)
Timeline
QC Microbiologist II
SKNV or Sincerus Pharmaceutical
02.2023 - Current
QC Microbiologist
New Vision Pharmaceuticals
01.2019 - 02.2023
Quality Control Inspector
IQ Formulations, LLC
04.2018 - 11.2018
QC Microbiologist I
International Medical Industries
02.2016 - 04.2018
Bachelor of Science - Medical Laboratory Technologist or Medical Laboratory Scientist
University of Carabobo
Bachelor of Science - High school diploma
Romulo Gallegos
Clinical Laboratory Scientist -
American Medical Technologist (AMT)