Kelsey Harris
Hatfield,PA
Summary
Dynamic Principal Scientist Group Leader at Eurofins Lancaster Laboratories, adept at driving cGMP compliance and fostering employee mentorship. Proven track record in developing training materials and managing deviation investigations, enhancing operational efficiency. Skilled in technical documentation and cross-functional collaboration, ensuring data integrity and compliance across multiple departments.
Overview
10
10
years of professional experience
Work History
Principal Scientist Group Leader
Eurofins Lancaster Laboratories Professional Scientific Services
07.2023 - Current
- Collaborated with stakeholders to discuss and creatively resolve cGMP compliance conflicts.
- Mentored employees to enhance their familiarity with new or revised processes.
- Developed departmental procedures and standard operating procedures in support of departmental changes and compliance requirements.
- Managed the assessment and revision of training requirements and processes.
- Developed and updated tools used for training compliance purposes.
- Owned and coordinated deviation investigations from initiation to closure.
- Managed documentation creation and reviews across multiple departments.
- Implemented and managed the creation and revision of electronic equipment logs.
- Organized the archival of experimental and personnel records.
Senior Scientist
Eurofins Lancaster Laboratories Professional Scientific Services
04.2022 - 07.2023
- Created new training materials and guidance documents.
- Responsible for the review process from training to problem solving.
- Managed the training of new employees for laboratory experimental support and the technical review process.
- Reviewed laboratory data to ensure data integrity and compliance.
- Evaluated technical documentation to assess if the data supported all drawn conclusions.
Scientist III
Eurofins Lancaster Laboratories Professional Scientific Services
10.2020 - 04.2022
- Trained new employees for laboratory experimental support and the technical review process.
- Reviewed laboratory data to ensure data integrity and compliance.
- Evaluated technical documentation to assess if the data supported all drawn conclusions.
Scientist II
Eurofins Lancaster Laboratories Professional Scientific Services
10.2019 - 10.2020
- Reviewed laboratory data to ensure data integrity and compliance.
- Evaluated technical documentation to assess if the data supported all drawn conclusions.
- Contributed to the process of implementing new laboratories and equipment.
Scientist I
Eurofins Lancaster Laboratories Professional Scientific Services
11.2015 - 10.2019
- Coordinated multiple investigations to determine investigation scope, root cause, and appropriate corrective and preventative actions.
- Coordinated department change control objectives.
- Created a tool for tracking the statuses of the departments change controls.
- Collaborated with internal and external company groups to obtain necessary resources.
Education
Bachelor of Science Degree - Biochemistry
Misericordia University
Dallas, PASkills
- cGMP compliance
- Training development
- Technical documentation
- Deviation management
- Process improvement
- Employee mentorship
- Effective communication
- Attention to detail
- Cross-functional collaboration
- Collaborative mindset
- Technical writing expertise
- Team building and mentoring
Timeline
Principal Scientist Group Leader
Eurofins Lancaster Laboratories Professional Scientific Services
07.2023 - Current
Senior Scientist
Eurofins Lancaster Laboratories Professional Scientific Services
04.2022 - 07.2023
Scientist III
Eurofins Lancaster Laboratories Professional Scientific Services
10.2020 - 04.2022
Scientist II
Eurofins Lancaster Laboratories Professional Scientific Services
10.2019 - 10.2020
Scientist I
Eurofins Lancaster Laboratories Professional Scientific Services
11.2015 - 10.2019
Bachelor of Science Degree - Biochemistry
Misericordia University
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