Kelly Larson
Deer Park,WI
Summary
Experienced Quality Assurance Professional with over 20 years in manufacturing industry. Skilled in motivating teams and analyzing problems to find innovative solutions. Proven track record of career advancement and handling increased responsibility. Thrives in fast-paced environments. Excels in teamwork, communication, and problem-solving, ensuring seamless collaboration with cross-functional teams to maintain product excellence and reliability
Overview
19
19
years of professional experience
Work History
Quality Assurance Lead
Otsuka America Pharmaceuticals, Inc
02.2023 - Current
- Facilitate effective communication between CDMO team and top management at Otsuka through regular collaboration and issue escalation
- Provided valuable QA support to the team during the IND submission process and successfully completed annual IND report
- Successfully integrated a new eQMS system into operations, resulting in streamlined processes that meet regulatory requirements
- Negotiate quality and supply agreements with suppliers
- Perform supplier audits, internal audits at CDMO and host regulatory inspections
Senior Manager, Product Quality and Asset Management
DiaSorin
Stillwater, MN
11.2020 - 02.2023
- Managed and led a team consisting of Microbiologists, Asset Management, and Validation personnel as part of department merge with Quality
- Managed product quality records such as CAPA, non-conformances, and risk management
- Managed Preventative Maintenance and Calibration program for equipment assets
- Led procurement efforts for new equipment, ensuring execution of equipment qualification and drafting of protocols
- Maintained adherence to PMA requirements of 21 CFR 820 while continuously enhancing the Environmental Monitoring program
- Collaborated with project teams as a Quality Engineer representative to drive operational improvements
- Led project management for the development and validation of a molecular product line, overseeing the complete renovation of an existing lab into a new space
Senior Manager, Asset Management and Facilities (Interim)
DiaSorin
01.2020 - 11.2020
- Managed Reagent, Facility, and custodial teams while acting as interim Facility Manager during recruitment
- Oversaw multimillion-dollar budget for capital and MRO expenditures
- Negotiated RFQ to decrease spending while maintaining vendor performance
- Oversaw external contractor management and maintained up-to-date safety training
- Participated in COVID response team; maintained a clean and sanitized work environment through the implementation of cleaning stations and regular office disinfection
- Led the implementation of a new EAM system as the US Technical leader for an inter-site project
- Implemented effective protocols for assessing the eligibility of essential infrastructure tools like steam sterilizers, generators, and controlled environments
- Successfully oversaw the project management of an 11,000 ft² office remodel, focusing on the installation of new cubicle furniture
- Implemented essential quality records like change requests, NCRs, deviations, and CAPAs
Manager, Reagents Manufacturing
DiaSorin
06.2017 - 01.2020
- Oversaw and coordinated a small team of four individuals, each with distinct roles and responsibilities within the Operations department.
- Managed $1M remodel of Labware Washing and Reagent Prep area, implementing 5S and Lean methodologies to enhance product flow and space utilization
- Led project to establish a new Environmental Control program and gain PMA approval.
- Acted as the main Bioburden technician during the absence of the department’s microbiologist
- Led the team in improving quality-related decision-making processes and implementing effective quality record-keeping practices.
- Maintained and organized asset records, while overseeing the implementation of calibration and preventative maintenance procedures for equipment.
Quality Engineer
Phillips-Medisize
New Richmond, WI
01.2017 - 06.2017
- Managed quality for diverse customer portfolio of 46 accounts while ensuring effective communication with manufacturing facility
- Assumed responsibility for rectifying supplier performance problems by implementing necessary corrective actions
- Facilitated communication among engineering teams, manufacturing, and quality departments
- Contributed to the advancement of continual improvement/innovation efforts through involvement in corrective actions and internal/external audits
- Monitored production activities to ensure conformance to established methods and procedures
Scientist
Surpass, Inc
Osceola, WI
07.2016 - 01.2017
- Designed and executed scientific research projects
- Developed and managed client/sponsor relationships
- Generated concise reports to summarize findings from both non-GLP and GLP studies
Manager, LIAISON Reagent Manufacturing
DiaSorin
Stillwater, MN
01.2015 - 06.2016
- Managed 20 individuals in four sub-groups within the LIAISON Department's team
- Assisting in the development of new products and their transition to manufacturing
- Formulated annual operating budget, provided monthly summaries and tracked department spending
- Played an active role on several cross-functional teams such as Risk Management, CAPA board, and Health and Safety committee
Manager, Serum Proteins
DiaSorin
01.2014 - 12.2014
- Led and motivated diverse teams of ten employees in the management of EIA/IFA and Serum Protein departments
- Launched aggressive efforts to rectify issues within the Serum Protein department
- Ensured the validation of new manufacturing equipment and maintained up-to-date preventative maintenance and calibration activities
- Primary liaison for largest customer of Serum Protein product line, generating annual sales of 3M
- Drastically improved DiaSorin’s working relationship with customer and jointly devised and implemented corrective programs
Manager, EIA/IFA Reagents
DiaSorin
07.2006 - 12.2013
- Provided technical core competencies for production and maintenance of EIA/IFA diagnostic products
- Led validation and transfer of three monoclonal antibody cell lines production from DiaSorin Italy to the US, accomplishing the task within a tight deadline of six months
- Served as interim LIAISON Bone and Mineral supervisor from May 2012 - December 2012, until permanent position was filled by Human Resources
- Ensured compliance with regulatory requirements and industry standards
Process Scientist, EIA/IFA
DiaSorin
03.2005 - 07.2006
- Performed reagent formulation, material processing and quality control on raw materials, reagents and finished kits following established protocols
- Documented all laboratory activities in compliance with established standards and regulations
Education
Bachelor of Science - Animal Science - Meat Animal Emphasis with Business Option
University of Wisconsin – River Falls
01.2002
Skills
- Operational Improvements
- Cross-Functional Team Collaboration
- Quality Management Systems
- Project Management
- Analytical Thinking
- Continuous Improvement
- Supplier Relationship Management
- Regulatory Compliance
- Internal Auditing
- Process Validation
Timeline
Quality Assurance Lead
Otsuka America Pharmaceuticals, Inc
02.2023 - Current
Senior Manager, Product Quality and Asset Management
DiaSorin
11.2020 - 02.2023
Senior Manager, Asset Management and Facilities (Interim)
DiaSorin
01.2020 - 11.2020
Manager, Reagents Manufacturing
DiaSorin
06.2017 - 01.2020
Quality Engineer
Phillips-Medisize
01.2017 - 06.2017
Scientist
Surpass, Inc
07.2016 - 01.2017
Manager, LIAISON Reagent Manufacturing
DiaSorin
01.2015 - 06.2016
Manager, Serum Proteins
DiaSorin
01.2014 - 12.2014
Manager, EIA/IFA Reagents
DiaSorin
07.2006 - 12.2013
Process Scientist, EIA/IFA
DiaSorin
03.2005 - 07.2006
Bachelor of Science - Animal Science - Meat Animal Emphasis with Business Option
University of Wisconsin – River Falls
Similar Profiles
Eny IbiokEny Ibiok
Clinical Technical Integration Specialist at Otsuka PharmaceuticalsClinical Technical Integration Specialist at Otsuka Pharmaceuticals
MoNique GonzalezMoNique Gonzalez
Quality Control and Analytical Services Assoc. at Otsuka PharmaceuticalsQuality Control and Analytical Services Assoc. at Otsuka Pharmaceuticals
Tracy VissingTracy Vissing
Executive Long Term Care Neuroscience Area Manager at Avanir Pharmaceuticals /OtsukaExecutive Long Term Care Neuroscience Area Manager at Avanir Pharmaceuticals /Otsuka