Cari Johnson
Longmont,Colorado
Summary
Experienced professional that is results-driven with a solid track record in delivering quality work. Recognized for exceptional problem-solving abilities, strong communication skills, and commitment to quality and compliance. Passionate about continuous improvement contributing to organizational success. And above all, dedicated to the patients we serve.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Specialist OpEx
KBI Biopharma
Boulder, CO
09.2021 - Current
- Developed and implemented operational excellence strategies to increase efficiency and reduce costs.
- Analyzed internal processes and identified areas for improvement, resulting in improved customer satisfaction.
- Collaborated with stakeholders across departments to develop innovative solutions that met organizational objectives.
- Designed training programs on operational excellence best practices for employees at all levels of the organization.
- Facilitated cross-functional meetings to review progress towards achieving goals related to operational excellence initiatives.
- Provided guidance on the development of SOPs that adhere to company policy and industry regulations.
- Configured and implemented Planview for project scheduling.
- Host regular Gemba walks to ensure workplace safety.
- Executed sustainability initiatives.
QC Specialist - Sample Management
Novartis Gene Therapies
Longmont, CO
04.2019 - 07.2021
- Conceptualized and executed the Colorado QCSM Program, ensuring robust data integrity.
- Fostered strong cross-departmental collaboration throughout the network.
- Evaluated procedures, protocols, sampling plans, and other GxP documents for compliance, process development guidance, and continuous improvement.
- STARLIMS admin engaged in the site LIMS implementation.
- Served as LIMS subject matter expert.
- Supported timely regulatory commitments by updating procedural documentation.
- Contributed to pre-audit preparation through QCSM storyboard development.
- Engaged in audit processes as QCSM SME and backroom support.
- Collaborated with the data integrity team to process map the sample management program and identify risks.
- Executed lot release tasks for QC, producing Certificate of Analyses for upstream and drug substance lots.
Senior Quality Control Analyst
AstraZeneca
Boulder, CO
06.2016 - 03.2019
- Designed, implemented, and successfully sustained all aspects of the QC Sample Management Program.
- Authored comprehensive procedures for QC Sample Management implementation.
- Forecasted quality control testing to align with manufacturing schedule.
- Facilitated LabWare LIMS design, qualification, implementation, and user training.
- Managed LIMS static data
- Developed and enhanced various global and site-level procedures for LIMS administration.
- Directed coordination efforts with third-party labs
- Investigated and authored QC deviation records.
- Developed and implemented corrective and preventive actions (CAPAs).
- Managed QC lot release and disposition.
Quality Assurance Specialist I
KBI Biopharma
Boulder, CO
10.2015 - 06.2016
- Performed batch record review.
- Monitored production operations for conformance to established quality standards.
- Reviewed and approved quality-related documents, ensuring compliance with internal and external standards.
- Reviewed and approved deviation and CAPA records.
- Inspected and released raw materials, ensuring quality standards were met.
- Tracked Vendor Change Notifications and initiated impact assessments.
Quality Assurance Associate II
Amgen (via AlphaPro Temps)
Longmont, CO
03.2013 - 03.2015
- Data verified, reviewed, and approved, regulatory submissions and technical documents.
- Authored SOPs, clinical and commercial master data spreadsheets, and lot release and stability trend chart.
- Independently and effectively supported multiple projects across various products with competing priorities.
Scientist, Group Leader
Amgen (via Eurofins Lancaster Laboratories)
Boulder, CO
04.2012 - 10.2012
- Led the Lancaster Laboratories team within the Amgen Analytical Sciences department.
- Executed cell-based Bio-ELISAs
- Supported routine testing and process characterization studies.
Research Associate
Amgen (via AeroTek)
Boulder, CO
08.2010 - 07.2011
- Executed diverse bioassay testing for various methods and products.
- Performed analytical method development, optimization, and remediation.
- Analyzed data using statistical software packages, such as JMP and SAS.
Research Associate II
GlobeImmune
Louisville, CO
07.2008 - 07.2010
- Performed a variety of laboratory tests on pancreatic cancer patient blood samples, including PCR, ELISA, DNA sequencing, cell culture, and western blot.
- Worked in a GMP Biosafety Level II lab with bloodborne pathogen and radiation training.
- Authored deviation and CAPA records
- Maintained sample documents, files, and databases.
Education
Master of Science - Biomedical Sciences
Colorado State University
Fort Collins, CO01-2009
Bachelor of Science - Microbiology
Colorado State University
Fort Collins, CO01-2008
Bachelor of Science - Biology
Colorado State University
Fort Collins, CO01-2006
Skills
- LIMS Administration (LabWare / STARLIMS)
- Data Integrity / Audits
- cGMP compliance
- Technical Writing / SOPs
- Process Optimization
- Lean / Continuous improvement
- Excellent problem-solving skills
- Microsoft Excel, PowerPoint, and Word / Formatting / Templates
- Sustainability
Certification
- Lean Professional Certification
Timeline
Senior Specialist OpEx
KBI Biopharma
09.2021 - Current
QC Specialist - Sample Management
Novartis Gene Therapies
04.2019 - 07.2021
Senior Quality Control Analyst
AstraZeneca
06.2016 - 03.2019
Quality Assurance Specialist I
KBI Biopharma
10.2015 - 06.2016
Quality Assurance Associate II
Amgen (via AlphaPro Temps)
03.2013 - 03.2015
Scientist, Group Leader
Amgen (via Eurofins Lancaster Laboratories)
04.2012 - 10.2012
Research Associate
Amgen (via AeroTek)
08.2010 - 07.2011
Research Associate II
GlobeImmune
07.2008 - 07.2010
Master of Science - Biomedical Sciences
Colorado State University
Bachelor of Science - Microbiology
Colorado State University
Bachelor of Science - Biology
Colorado State University
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