Jaythe Silva
Los Angeles
Summary
Dynamic and results-driven Quality Control Microbiologist with a strong track record of leading microbiology operations within regulated biotechnology and biopharmaceutical environments. Brings extensive expertise in microbial method development and validation, environmental monitoring programs, aseptic manufacturing oversight, contamination control strategies, and product release testing in compliance with FDA, EMA, and ICH guidelines. Proven ability to manage and mentor high-performing laboratory teams, optimize QC workflows, and ensure timely, accurate, and compliant analytical support for clinical and commercial manufacturing. Adept at driving continuous improvement initiatives, supporting regulatory inspections, and strengthening quality systems to maintain a state of control across facilities. Committed to fostering a culture of scientific excellence, operational efficiency, and patient-focused quality.
Resourceful Microbiology Supervisor known for high productivity and efficient task completion. Possess specialized skills in microbial identification, sterility testing, and environmental monitoring. Excel in leadership, communication, and problem-solving to ensure laboratory operations meet quality standards.
Overview
9
9
years of professional experience
1
1
Certification
Work History
QC Microbiology Supervisor
GenVivo, Inc.
Pasadena
11.2021 - Current
- Implemented quality control measures to ensure accuracy and reliability of test results, resulting in a 40% decrease in errors
- Developed and optimized laboratory processes for efficient sample handling, reducing turnaround time by 20%
- Managed the inventory of laboratory supplies and reagents, ensuring an adequate stock level at all times
- Collaborated with cross-functional teams to develop new testing methodologies and improve existing protocols
- Performed data analysis on test results using statistical software, identifying trends and patterns for further investigation
- Maintained compliance with regulatory requirements such as USP, CFR, FDA, and ISO guidelines
- Conducted regular performance evaluations for staff members, providing constructive feedback to promote professional growth
- Coordinated training programs for new hires on laboratory techniques, safety procedures, and quality assurance practices
- Led validation studies for new equipment or assays to ensure accuracy and reliability of results before implementation
- Maintained accurate records of all tests performed in accordance with established documentation guidelines
- Participated in proficiency testing programs to assess the competency of the microbiology lab
- Identified areas for process improvement within the microbiology department through data analysis
- Provided technical expertise to resolve complex issues related to sample processing or result interpretation
- Implemented cost-saving initiatives without compromising quality standards
- Mentored junior staff members on advanced laboratory techniques and troubleshooting methods
- Managed the scheduling of laboratory staff to ensure adequate coverage for testing demands
- Participated in continuous education programs to stay updated on the latest advancements in microbiology
- Developed and maintained positive relationships with vendors, ensuring timely delivery of supplies and equipment
- Implemented a comprehensive training program on biosafety practices, resulting in a 20% decrease in incidents
- Conducted regular audits of laboratory processes to identify areas for improvement and ensure compliance with regulations
- Collaborated with IT department to implement new laboratory information management system (LIMS)
- Led cross-functional teams in the development and validation of new assays or methodologies
- Served as a subject matter expert during regulatory inspections or audits
- Contributed to research projects by conducting experiments, analyzing data, and preparing scientific reports
- Oversight of 2 microbiologists and 3 environmental monitoring (EM) technicians
- Validation of compressed air monitoring system
- Validation of endotoxin method for drug substance/drug product
- Completion of in-vitro and in-vivo disinfectant efficacy study
- Validation of rapid endotoxin method - chromogenic
- Maintaining all quality control equipment/instruments - PM/Calibration Services/Check-in/Check-Out
- Completion of environmental monitoring performance qualification (EMPQ) for 10+ cleanrooms (ISO 5, ISO 7, & ISO 8)
- Validation of bioburden method for drug substance/drug product
- Validation of cleaning verification method for product changeover
- Semi-annual review and revision of all microbiological related SOPs and STMs per contamination control strategy
- Implementation of bioburden suitability testing SOP
- Implementation of protocols for EM contamination prevention
- Validation of 8 microbiological equipment and materials related autoclave cycles
- Validation of anaerobic gas system for CO2 related EM samples
- Implementation of 35+ microbiological protocols
- Completion of air visualization study for all cleanrooms
Manufacturing Supervisor
Bimeda Animal Health Pharmaceutical
Irwindale
10.2020 - 11.2021
- Supervise the daily manufacturing and environmental monitoring (EM) operations for injectable and powder operation manufacturing lines. Maintain equipment, tools, and processes within each area (work orders, calibrations, inspections, and purchasing).
- Respond to alarms (differential pressure, HEPA velocity, temperature/humidity, particle) properly and accurately escalate the issue to supervision/management, and the appropriate support groups when necessary
- Coordinate manufacturing and EM processes related issues with Quality Operations prior to intervening in the system
- Train and supervise across all manufacturing and EM personnel within multiple manufacturing suites.
- Provide a positive and equitable working environment emphasizing the Bimeda Leadership Behaviors
- Emphasize the Safety and Quality commitments of the manufacturing department to make decisions concerning these commitments within the area.
- Ability to utilize resources, time, and raw materials in the most efficient and productive manner possible.
- Identify/prioritize/provide resources in an area to assist management to meet the annual operational plan and budgetary commitments.
- Facilitate and verify appropriate training for employees in the area (including but not limited to cGMP, job skills, and safety)
- Ensure compliance with all cGMP rules, good document practices (GDP), product specifications, standard operating procedures (SOP), and FDA requirements as required.
- Commit to employee feedback and developmental process to support Bimeda Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.
- Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.
- Provide leadership to assess and provide guidance and risk assessments regarding requirements for the design of the manufacturing.
- Create and Update EM and Manufacturing SOPs and batch records.
- May supervise more than one group at one time.
- Review, correction, and submission of completed master production batch records.
- Backflushing of all raw materials, labels, and shipper materials in QAD system for shipment.
- Maintain (purchase, review, and identification) manufacturing materials such as sterile and non-sterile garments, goggles, safety equipment, hand sanitizers, cleaning solution, EM measuring equipment, masks, etc.
- Drafting and final submission of Environmental Notification, Deviation, OOS, quarterly/annual, change control, CAPA reports.
Microbiology Supervisor
Bimeda Animal Health Pharmaceutical
Irwindale
06.2019 - 10.2020
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and meets housekeeping and cleanliness standards
- Reviews all documentation for accuracy and completeness and ensures that it's in compliance with current GMPs/GLP, Good Documentation Practices, SOPs and company policies
- Specialize in various microbial testing such as Sterility test, Bioburden, GPT, Media Preparation, and LAL testing.
- Provides technical support in the area of Microbiology to the Manufacturing and Validation departments
- Develops and validates testing methods used in routine analysis of incoming raw materials and finished products
- Participates in internal and external audits as required. Acts as a subject matter expert and administers gown training for production staff
- Communicates to the Manager any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations
- Follows GMP and regulatory requirements and ensures quality standards are met. Observes and supports all safety guidelines and regulations
- Responsibility includes to develop validation protocols, write related project reports. In addition, update laboratory documentation, SOPs and test methods as required.
- Provide SME (Subject Matter Expert) support in the area of microbiology for laboratory and manufacturing operations.
- Author, revise, and review standard operating procedures, test methods, work instructions, and protocols
- Lead the method development and suitability activities for microbiology methods of new products
- Mentor, train, and lead microbiology staff members
- Scheduling, training and leading environmental monitoring technician staff members
- Investigate and troubleshoot equipment, testing, and process abnormalities
- Order laboratory supplies ensuring inventory is fully equipped for each staff member
- Perform root cause analysis of environmental excursions, deviations, and non-conformances. Subsequently writing investigational reports for release of batch.
- Writes quarterly trend report for environmental monitoring
Microbiologist
Bimeda Animal Health Pharmaceutical
06.2018 - 06.2019
- Perform microbiological endotoxin Limulus Amebocyte Lysate (LAL) testing on water samples, in-process product samples, raw materials, and environmental monitoring (EM) samples as directed by the QA Director and/or QC Specialist.
- Perform all testing practicing aseptic techniques during all experiments and tests
- Perform validation of Limulus Amebocyte Lysate reagent sensitivity.
- Perform measurement of Hydrocarbons and water vapor in compressed air.
- Perform microbiological testing of WFI/RO via membrane filtration method.
- Perform preparation of media, dilution and rinsing fluids for sterility tests and bioburden testing
- Perform sterility testing of sterile media and fluids.
- Determining the bacteriostatic and fungistatic activity of a product prior to sterility testing.
- Perform count of colony forming units (bacteria, yeast, and mold) on Petri plates.
- Perform sterility testing on final products and raw materials via membrane filtration method or direct transfer method.
- Perform Growth Promotion and Biological Indicator testing.
- Isolate, maintain, and passage of pure microbial cultures (cell culturing/Sub-culture)
- Prepare and maintain frozen cultures of microbial isolates.
- Perform various microbial identification tests (microscopy, genetic, biochemical, and/or morphological).
- Quarantine and release of raw materials.
- Maintain microbial identification database within Bimeda database.
- Compile, maintain, and enter data into computer database for reporting and trending purposes.
- Record and inspect microbiological/chemical test results against company specifications.
- Responsible for laboratory equipment maintenance and calibration, housekeeping, and other lab support functions
- Maintain sample logs daily to ensure timely testing and tracking of all samples.
- Maintain instrument usage and calibration logs based on instrument usage during the preparation, equipment troubleshooting, and testing of samples.
- Strict adherence to procedures and practices according to FDA regulations.
- Strong emphasis on documentation according to FDA regulations.
- Perform microbiological bioburden testing of raw product and materials via membrane filtration method.
- Cleaning and tracking air velocity of HEPA/Laminar Flow Hoods.
- Perform Media Preparation (Autoclaved WFI, Dey-Engley Broth, Fluid A, Fluid D, TSB, FTG, Phosphate Buffer, Isopropyl Myrisate, 0.9% Saline, SDA plates)
- Perform pH monitoring of prepared media prior to and after autoclave cycle.
- ELISA (Direct, Indirect, Sandwich, and competitive)
- Perform microbiological testing of compressed air and nitrogen gas.
- Enumeration of microorganisms verifying supplier's certificate of analysis.
- Microbiological testing of BI samples for validation purposes.
- Preparation of microbiological instruments and tools for autoclave.
- Buffer and reagent preparation
- Perform investigational report writing (Environmental Notifications, Environmental Monitoring, Process Deviations, OOS).
- Current Class 100/Grade A sterile gown qualified.
- Administer Class 100/Grade A sterile gown qualification test.
- Investigational plating, swabbing, air sampling, and particle monitoring of potential environmental excursion areas.
- Generate, revision, development, and maintenance of SOP's and sample logs/forms to FDA, EU, OSHA, ISO, ICH, and USP standards.
- Coordinated on-going improvements to production cleaning SOP to reduce number of environmental excursions with production staff and leaders.
- Perform cleaning solution efficacy study of cleaning solutions (Bleach, Phenol, BacDown, Spor-Klenz, IPA).
- Good working knowledge of USP, FDA, ISO and ICH requirements
Manufacturing Technician
Shire Pharmaceutical
07.2017 - 06.2018
- Bio-burden removal/treatment with LpHse, Liquinox, 1500 PPM solution, Spor-Klenz, and 500 PPM solution according to SOP, cGMP, and GDP
- Preparation of varying solutions within controlled environment and subsequent pH testing of prepared solutions
- Special gowning qualified within manufacturing post and pre-viral areas according to Shire SOP/GMP
- Formal documentation of all prepared solutions and microbial containment tasks within manufacturing areas. Documented within log books, including special work orders supervised by lead operators
- Fractionation harvest aid followed by removal of bio-hazardous waste post-harvest, specifically Cellpure filter aid and fractionation byproduct waste
- Plasma bag/bottle teardown and processing within controlled environment areas
- Preparation of biological samples for microbial contamination screening
- Analysis of microbial contamination screening (turbidity, PFU, etc.)
Education
Bachelor of Science - Microbiology, Biotechnology
California State Polytechnic University
08.2013 - 01/2018
Skills
- Laboratory compliance management
- Quality assurance
- Aseptic technique
- Protein purification
- Biometrics
- CGMP
- Performance evaluation
- Laboratory resource allocation
- Technical Proficiency
- Laboratory team leader experience
- Chromatography
- Pharmaceutical regulatory compliance
- Electrophoresis
- Supervising experience
- Gel electrophoresis
- Laboratory regulatory affairs
- Bio-burden
- Media preparation
- Laboratory inventory records management
- Data analysis skills
- Environmental research
- Laboratory training coordinator experience
- Technical project & program manager supervisory experience
- Managing laboratory operations teams
- Chemical handling
- FDA regulations
- Laboratory budgeting
- Laboratory safety
- Problem-solving
- Resource allocation
- Laboratory research project leader experience
- Managing laboratory optimization budgets
- Research setting experience
- Purification
- Ion
- GMP
- Biological sample management
- Project coordination
- Team management
- ISO standards
- Microscope
- Spectrophotometer
- HACCP
- Research design
- Technical writing
- Technical documentation
- Fermentation
- Biology research
- Staff development
- Laboratory operations manager experience
- Laboratory supervisor experience
- Laboratory equipment maintenance
- Laboratory staff training
- Implementing laboratory protocols
- Dna
- Bioburden
- Qpcr
- Strategic planning
- Laboratory quality control
- Laboratory experience
- Conflict resolution
- Laboratory management
- Elisa
- Manufacturing
- Microsoft Office
- Nmr
- Quality audits
- Titration
- Productivity software
- Rna
- Laboratory staff supervision
- Management
- Polymerase Chain Reaction
- Salt Fractionation
- Aseptic Technique
- H1/C13 NMR Analysis
- Protein Purification
- Agarose Gel Electrophoresis (AGE)
- ANOVA
- Plaque Assay
- Fractional Distillation
- Phage Isolation/Amplification
- Titration/Serial Dilution
- TLC Testing
- Ultracentrifuge/Centrifuge
- AA Spectrophotometer
- Infrared Spectroscopy
- Ion Exchange Chromatography
- Protein Assay
- Cell Culturing
- Media Preparation
- Microscope slide staining
- Electron Microscope Operation
- ELISA
- Bio-burden Removal
- Chemical Solution Preparation
- Proper Documentation
- Fractionation Harvesting
- Molarity/Mole Unit Conversions
- Reverse Transcription-qPCR
- Microbial Tube/Plate Streaking
- Microbial detection method
- Gel Electrophoresis (SDS-PAGE)
- Western/Southern/Northern Blot
- Immunoblot
- Microbial testing
- Quality control
- Method validation
- Regulatory compliance
- Environmental monitoring
- Data analysis
- Project management
- Process optimization
- Staff training
- Problem solving
- Effective communication
- Cross-functional collaboration
- Leadership skills
- Assay development
- Hazardous waste management
- Molecular biology
- Microscopy techniques
- Cell culture
- Sterilization methods
- Microbial identification
- Good manufacturing practices
- Sample collection
- Biological safety
- Decision-making
- Vendor management
- Employee supervision
- Process implementation
- Adaptability
- Multitasking
- Employee performance evaluations
- Budget planning
- Continuous improvement
- Personnel management
- Organizational skills
- Critical thinking
- Records management
Certification
Safe Quality Food Certification
Languages
English
Personal Information
Willing To Relocate: Anywhere
Timeline
QC Microbiology Supervisor
GenVivo, Inc.
11.2021 - Current
Manufacturing Supervisor
Bimeda Animal Health Pharmaceutical
10.2020 - 11.2021
Microbiology Supervisor
Bimeda Animal Health Pharmaceutical
06.2019 - 10.2020
Microbiologist
Bimeda Animal Health Pharmaceutical
06.2018 - 06.2019
Manufacturing Technician
Shire Pharmaceutical
07.2017 - 06.2018
Bachelor of Science - Microbiology, Biotechnology
California State Polytechnic University
08.2013 - 01/2018