Kari Lachaussie
New Richmond,WI
Summary
Experienced Quality Systems Training Coordinator with a strong background in quality systems. Possessing 6 years of management experience and a combined total of 18 years in the medical device industry. Skilled in effectively managing all support functions and facilitating clear communication between trainers and participants. Sincerely dedicated to developing comprehensive training plans tailored to the ever-changing needs of the company and its employees, with the goal of fostering high-performing individuals and teams.
Overview
19
19
years of professional experience
2
2
Certification
Work History
Quality Systems Specialist/Training Coordinator
DiaSorin
2022.04 - Current
- Create, modify and maintain user accounts in the quality management system
- Maintain and administer compliance training using SmartSolve(QMS) and Schoox(LMS)
- Enhanced product quality by implementing innovative process improvements and quality control measures.
- Develop and facilitate training curriculum for annual GMP training, onboarding/offboarding, and On-The-Job training checklists to verify employee competence
- Processes and creates document revisions for various operating procedures
- Accesses training risk for SOP’s, GOP’s and work instructions and creates training assessments for procedures as needed
- Participate in internal and external audits in order to maintain 21 CFR Part 820 Medical devices, ISO 13485:2016, ISO 9001:2015 certification and MDSAP certification
- Collaborate with managers, supervisors and various SME to create robust training plans/roles for employees to ensure employee training is current and relevant
- Produces learning solutions using various software tools such as Microsoft office, Adobe Pro, Snag it, Visio.
Manufacturing Supervisor
DiaSorin
2015.11 - 2022.04
- Communicate an understanding of organizational and group objectives and empowers group to solve problems and meet manufacturing and project deadlines
- Advanced working knowledge of computer programs such as SAP, SMARTSOLVE, Schoox, Microsoft Suite, Minitab and SuccessFactors
- Improved production efficiency by implementing lean manufacturing principles and streamlining processes.
- Supervised a team of skilled workers, providing guidance, training, and performance evaluation for continuous improvement.
Process Scientist III
DiaSorin
2005.01 - 2015.11
- Manage manufacturing schedules for HEp-2, Crithidia Lucilae and hybridoma cell cultures for slide production
- Manufactured ELISA kits
- Trained staff members on proper laboratory procedures, fostering a culture of safety within the workplace environment.
- Streamlined lab workflows by implementing Lean Six Sigma principles, reducing waste while maintaining high-quality outcomes.
- Analyze testing results of technical manufacturing, quality control or product performance to determine acceptability of product relative to established requirements
- Assist with investigations for root cause determination and perform corrective actions as needed
- Maintain laboratory and laboratory equipment.
Education
B.A Biology -
University River Falls
12.2005
Skills
- Optimistic and Outgoing
- Organizational Skills
- Team Leadership
- Process Improvement
- Training Development
- Creative and Proactive
- Conflict Resolution
- Detail Orientated
Continued Education
- Leading with Purpose, 10/21/19
- LHH: Building the Capability to Lead Change, 09/17/19
- LHH: Build and Lead Accountable Teams, 06/06/19
- Foundation of Project Management, 03/06/19
- LHH Developing Resilience, 10/17/17
- Lean agent training, 10/02/17 - 10/04/17
- LHH: 360 Review/ Coaching Conversations, 06/2016
Projects
Ascites Transfer, November 1, 2015 - April 1, 2022
Effectively transferred seven hybridomas to DiaSorin Stillwater to facilitate the production of monoclonal antibodies.
Evaluated and refined DiaSorin Italy procedures to ensure compliance with the Institutional Animal Care and Use Committee (IACUC) guidelines.
Developed Standard Operating Procedures (SOP) and Work Instructions(WI) for costing purposes.
Established a Bill of Materials (BOM) and corresponding procedures.
Formed and managed an Ascites team.
Certification
- Certified Professional in Training Management(CPTM)- 12/05/2023
- Certified Lean Agent- 10/2019
Timeline
Quality Systems Specialist/Training Coordinator
DiaSorin
2022.04 - Current
Manufacturing Supervisor
DiaSorin
2015.11 - 2022.04
Process Scientist III
DiaSorin
2005.01 - 2015.11
B.A Biology -
University River Falls
- Certified Professional in Training Management(CPTM)- 12/05/2023
- Certified Lean Agent- 10/2019
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