EMMA BOONGALING
Richmond,CA
Summary
Experienced Director with strong project management and decision-making skills. Possesses comprehensive knowledge of Microbiology and adept at handling production, planning, and technical operations. Expertise lies in coordinating laboratory operations and effectively managing personnel resources to ensure timely completion of work.
Overview
28
28
years of professional experience
Work History
QC AD, Micro, Sterility & Raw Materials
Nutcracker Therapeutics
10.2022 - Current
- Provide QC Microbiology oversight for facility startup, including qualification and validation activities
- Provide technical leadership to develop and implement key capabilities in Microbiology and Sterility Assurance to support Nutcracker's cGMP manufacturing of mRNA therapeutics
- Manage Environmental Monitoring program and Aseptic Gowning Qualification program for production facility
- Subject matter expert in operational cGMP compliance for aseptic processing in cleanroom environments, microbial release/stability/EM testing controls, applicable regulatory requirements, and quality assurance practices
- Provide sterility programming expertise for GMP manufacturing and QC lab design, built out, commissioning and qualification
- Lead microbiological risk analyses of facility and processes that drive microbiological monitoring strategy and program
- Lead resolution of quality events (CAPA, OOS, investigations, etc) and direct support of audits and regulatory interactions
- Manage microbiological methods development, qualifications and verifications, including validation and implementation of BacTalert Rapid Sterility testing and implementation of manufacturing cleanrooms to GMP compliance
- Experienced with LabGuru, SAGE, Smartsheet, and Lucid.
- Review and release specifications for raw materials and other consumables.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Worked well in team setting, providing support and guidance.
- Self-motivated, with strong sense of personal responsibility.
Sr. QC Supervisor
BioMarin
03.2017 - 10.2022
- Microbiology lab supervisor for Viral Vector Gene Therapy division
- Duties include overseeing EM program (HVAC, utilities, and gases), coordination of EM PQ logistics during start up and shutdown of gene therapy facility and pilot plant facility
- Experience with product fill and process simulation, qualification of VHP decontamination cycle of Isolator 5400
- Participate in investigations of Alert/Action, excursions, and atypical results
- Generate Monthly/Quarterly EM trend reports and Annual Product Reports
- Monitor quality system metrics
- Created training program for both Analytical and Microbiology labs
- Experienced with MODA and LIMS.
- Supervised and directed quality control personnel through effective mentoring, coaching and work delegation
Senior Scientist
Roche Molecular Systems
10.2015 - 03.2017
- Aid with daily operations associated with Biorepository in the BioSpecimen Management (BSM) by management of inventory, processing, distribution, storage, and disposition of biological materials
- Review and revise procedures to ensure current practices are followed and to optimize lab processes
- Conduct and monitor biorepository management activities, such as, incoming, and outgoing biological material shipments, verification of materials, material distribution, communication with other project teams and external vendors
- Responsible for CAP (College of American Pathologists) accreditation activities which includes inspection of lab and personnel practices, review of all documents pertaining to BioSpecimen Management department (Acquisition Management, Data Management and BioRepository Lab) and implementing required changes to be in alignment with CAP accreditation
- Evaluate current BioRepository procedures and identify gaps, streamline opportunities, and process improvements
- Aided in implementation of first BioSpecimen Manangement system for use by Roche globally.
- Simultaneously managed several complex projects, meeting all pertinent milestones
QC Supervisor Microbial Identification Laboratory
Novartis Vaccines and Diagnostics
12.2011 - 06.2014
- Assist with establishment and continuous improvement activities which includes review of quality systems, documents, and methods for processing and ensuring quality in raw materials, intermediates, or finished products
- Troubleshoot problems in existing processes and proactively innovate new and effective strategies for problem resolutions.
- Supported audits and led teams to fully investigate quality control processes and root out deficiencies.
- Supervised and directed quality control personnel through effective mentoring, coaching and work delegation.
Senior QC Specialist
Bayer Healthcare
08.2008 - 12.2011
- Developed and implemented procedures to meet product quality standards.
- Inspected items and compared against standards to meet regulatory requirements.
- Created testing protocols to be used across product lines.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Validation of efficacy of disinfectants
- Assessed alert and action levels for Environmental Monitoring
QC Microbiology Supervisor
Baxter Healthcare
07.2006 - 07.2008
- Managed both BioSurgery Medical Device and BioScience Biologics Microbiology labs with 15 direct reports
- Provided and presented EM data trends for management review on monthly and quarterly basis
- Experience with qualification of cleanrooms
Sr. QC Validation Specialist
VaxGen, Inc.
02.2006 - 07.2006
- Documented entire validation process, noting changes or alterations completed.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Met tight deadlines to satisfy client demands and project timelines.
Laboratory Support Specialist- Bacteriology Lab
Kaiser Regional Laboratory
03.2001 - 01.2006
- Adhered to laboratory safety procedures to maintain compliance.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Operated and performed preventative maintenance on laboratory equipment and instruments.
- Performed several clinical microbiology testing such as Streptococcus Group B testing, specimen subcultures, fluid infection monitoring through use of BacTalert and Bactec 9240 instruments, susceptibility tests through Microscan Walkaway
Sr. QC Microbial Identification and Mycoplasma Lab Supervisor
BAYER HEALTHCARE
05.2002 - 09.2005
- Qualified rapid testing for sterility testing (Bactec 9240), microbial identification using Vitek system
- Implemented Mycoplasma testing in-house
Associate QA Scientist
Bayer Healthcare Pharmaceuticals Inc.
01.2000 - 05.2002
Microbiologist / Analytical Chemist
MORSE LABORATORIES, INC.
07.1998 - 12.1999
Microbiology Laboratory Technician
IDEXX VETERINARY SERVICES
06.1996 - 08.1998
Education
Bachelors of Science in Biological Science with field of concentration in Clinical Laboratory Science -
CALIFORNIA STATE UNIVERSITY
Sacramento, CA01.1996
Skills
- Good Manufacturing Practices
- Environmental Monitoring
- Commission of GMP cleanrooms
- Data Capture and Analysis
- Quality Control Data Compilation
- Quality SOPs Development
- Outside Testing Coordination
- Technical Writing
- New Testing Methodologies
- Attention to Detail
- Microbiology Analysis
- LabWare LIMS, MODA, LabGuru, Lucid, SAGE
- Teamwork and Collaboration
- Decision-Making
- Organizational Skills
- Continuous Improvement
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Success is not final; failure is not fatal: It is the courage to continue that counts.
Winston S. Churchill
Timeline
QC AD, Micro, Sterility & Raw Materials
Nutcracker Therapeutics
10.2022 - Current
Sr. QC Supervisor
BioMarin
03.2017 - 10.2022
Senior Scientist
Roche Molecular Systems
10.2015 - 03.2017
QC Supervisor Microbial Identification Laboratory
Novartis Vaccines and Diagnostics
12.2011 - 06.2014
Senior QC Specialist
Bayer Healthcare
08.2008 - 12.2011
QC Microbiology Supervisor
Baxter Healthcare
07.2006 - 07.2008
Sr. QC Validation Specialist
VaxGen, Inc.
02.2006 - 07.2006
Sr. QC Microbial Identification and Mycoplasma Lab Supervisor
BAYER HEALTHCARE
05.2002 - 09.2005
Laboratory Support Specialist- Bacteriology Lab
Kaiser Regional Laboratory
03.2001 - 01.2006
Associate QA Scientist
Bayer Healthcare Pharmaceuticals Inc.
01.2000 - 05.2002
Microbiologist / Analytical Chemist
MORSE LABORATORIES, INC.
07.1998 - 12.1999
Microbiology Laboratory Technician
IDEXX VETERINARY SERVICES
06.1996 - 08.1998
Bachelors of Science in Biological Science with field of concentration in Clinical Laboratory Science -
CALIFORNIA STATE UNIVERSITY
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