Shannon Karnacki
San Mateo,CA
Summary
Passionate about and dedicated to maintaining the quality system in order to ensure the safety, efficacy, potency and purity of biologics products. Total of 10 years’ experience working in various departments, including pilot plant manufacturing, commercial testing and clinical environments. Comprehensive understanding of all stages of the drug development process. Sound knowledge and assessment of how molecular characteristics, process changes and environmental parameters can affect quality. Routine support for all phase-related validation activities through compliance and technical review of potency data, change control and approval of GMP documents, as well as preparation and compilation of method validation documents for early and late stage submissions and BLA filing. Looking for a position in Quality Control, Quality Assurance, Clinical trials or Regulatory Affairs where I can utilize my background and skills. Knowledgeable professional offering 12 years of experience in quality control. Focused, detail-oriented and dedicated to continuous improvement and helping team produce top results. Collaborative Quality Control Analyst with excellent troubleshooting skills. Highly effective in working with clients, peers and [Job title]s. Experienced in [Type] inspections and mentoring others.
Overview
12
12
years of professional experience
Work History
QC Associate II
Genentech, Inc.
South San Francisco, CA
04.2013 - 07.2021
- Performed compliance and technical review of assay packets for potency methods (cell-based, non-cell-based, and ELISA), of data included in MVRs, MDHRs, memos and TRPs, and of cell culture binders, pipette logbooks, and equipment binders
- Reviewed LabWare LIMS and control trending data for PRD and GMP samples
- Reviewed Phase I and Phase III projects according to protocols, which includes all robustness, validation, minor variant and bridging studies, and data tables
- Performed review and change control for test procedures, SOPs and other GMP-controlled documents
- Collaborated with document authors and Change Control group to facilitate review and approval of CRs and GMP documents in Condor
- Identified gaps and vagueness in GMP documents and suggest improvements to Subject Matter Experts
- Supported method development, validation and lot release activities
- Supported Quality Investigations and provide written evaluation as needed
- Member of BT Template Team to revise existing as well as create new templates for BT colleagues to use for testing and validation activities
- Recorded, tracked and updated TrackWise and Condor metrics, and provide status reports to the applicable authors and reviewers
- Worked effectively with multiple teams to compile Method Validation Binders for submission to IMP QA on tight deadlines, ensuring that all assay packets, protocols, test procedures, summary tables, and worksheets are included according to regulations
- Assisted the testing group to make certain reagent binders, equipment logbooks and equipment qualification binders are always inspection-ready.
QA Specialist III
Abbott Hematology (contract)
Santa Clara, CA
05.2012 - 02.2013
- Reviewed Device History Records for instruments manufactured on site to ensure accuracy, completeness, and compliance with procedures
- Issued Certificate of Quality and released product into Finished Goods
- Followed up with discrepancies in documentation in order to release product.
Reagent Chemist I
Quidel Corporation (contract)
Santa Clara, CA
10.2011 - 02.2012
- Manufactured diagnostic (immunoassay) kits for autoimmune and bone diseases
- Tested ELISA kit components.
QC Analyst
Bayer HealthCare (contract)
Emeryville, CA
12.2010 - 10.2011
- Tested protein drug products using sub-visible particle counting (Micro Flow Imaging Technology)
- Involved in meetings to discuss changes to improve testing method
- Executed development studies in support of new methods
- Executed investigational studies
- Recognized, troubleshooted, and resolved problems associated with the equipment and testing
- Contributed to SOP and protocol revision and review.
Clinical Manufacturing Lab Technician
MedImmune, Inc. (contract)
Santa Clara, CA
05.2009 - 06.2010
- Scheduled weekly EM and any additional monitoring (i.e
- After area shutdowns, resampling, investigations)
- Interacted with QC Micro group to assist in data entry and verification
- Assisted with EM investigation studies resulting from alert and action limits or adverse trends
- Involved in setting up a lab to abide by FDA regulations and involved in Inspection Readiness
- Performed routine and dynamic environmental monitoring in ISO 8, ISO 7, and ISO 5 areas, and clean dry air (CDA) monitoring.
Education
Bachelor of Science - Biological Sciences
University of California, Davis
Davis12-2008
Skills
- Microsoft Word
- Excel
- PowerPoint
- Adobe Acrobat
- FileMaker Pro
- LIMS
- SoftMax Pro
- TrackWise
- Condor
- EDMS
- Quality Control Data Compilation
- Environmental Sampling and Testing
- Regulatory Submission Support
- Attentive and Observant
- Data Capture and Analysis
- Audit Assistance
- Standardized Testing Methodology
- Quality SOPs Development
- Adaptability and Flexibility
- Quality Issue Identification
- Specification Conformance
- Laboratory Equipment Calibration
- Finished Goods Inspection
- Testing Documentation
- Product Inspection
- Attention to Detail
- New Testing Methodologies
- Laboratory Computer Systems
- Corrective Actions
- LabWare LIMS
- Report Preparation
- Sampling Procedures
- Production Monitoring and Assessment
- Testing Protocols
- Documentation
- Sampling Protocols
- Technical Writing
- Protocol Development
- Equipment Calibration
- Testing Procedures
- Data Entry
- Word Processing
- Critical Thinking
Attributes
- Reliable
- Leader
- Charismatic
- Determined
- Driven
- Multitasker
- Excellent communicator and collaborator
- Creative
- Organized
- Detailed
- Excels under pressure
- Team player
- Inquisitive
- Fast learner
- Flexible
- Enthusiastic
- Passionate
Professional Highlights
- Perform compliance and technical review of assay packets for potency methods
- In depth understanding of cGMPs and quality standards
- Compliance review of 23 method validation projects and preparation of regulatory documents for BLA filing
- Review, upload and approval of technical reports and validation documents to an EDMS
- Perform change control for test procedures, SOPs, and other GMP-controlled documents
- Actively support method development, validation and GMP lot release activities
- Revision of test procedures, SOPs and protocols
- Involved in drug development
- Inspection readiness
- Performed GMP manufacturing, environmental monitoring, sub-visible testing
Affiliations
- Gardening
- Cooking
Timeline
QC Associate II
Genentech, Inc.
04.2013 - 07.2021
QA Specialist III
Abbott Hematology (contract)
05.2012 - 02.2013
Reagent Chemist I
Quidel Corporation (contract)
10.2011 - 02.2012
QC Analyst
Bayer HealthCare (contract)
12.2010 - 10.2011
Clinical Manufacturing Lab Technician
MedImmune, Inc. (contract)
05.2009 - 06.2010
Bachelor of Science - Biological Sciences
University of California, Davis
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