Kimberly Miller
Rochester,NY
Summary
Discover, Realize Opportunity, Deliver
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
23
23
years of professional experience
1
1
Certificate
Work History
Sr. Study Director
HIGHPOWER Validation and Testing Services
12.2014 - Current
- Develop testing protocol, facilitate study projects, review and analyze data/results
- Collaborated with cross-functional teams to ensure consistency in study design and execution, resulting in better communication across departments.
- Ensured regulatory compliance by meticulously maintaining accurate documentation for all studies conducted.
- Conducted thorough analyses of research findings to identify trends and areas for improvement, leading to enhanced study quality.
- Developed strong relationships with clients, providing regular updates on study progress and addressing concerns promptly.
- Mentored junior staff members, helping them develop their skills and contribute effectively to the overall success of the team.
- Led a team of researchers efficiently, providing guidance and support to maximize productivity and achieve project goals.
- Coordinated with external partners for outsourcing specialized tasks when necessary, ensuring timely completion without compromising quality.
- Assisted in business development efforts by showcasing technical knowledge during client meetings, leading to increased revenue opportunities.
- Optimized laboratory practices by identifying inefficiencies in workflows and implementing targeted improvements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Validation Scientist
Ortho-Clinical Diagnostics
01.2011 - 01.2013
- Assisted QC and R&D scientists and engineers in the integration, verification, and validation of immunohematology analyzers
- Conducted thorough investigations into deviations, identifying root causes and implementing appropriate corrective actions.
- Increased compliance with regulatory requirements through rigorous documentation practices and continuous improvement initiatives.&
- Increased compliance with regulatory requirements through rigorous documentation practices and continuous improvement initiatives.
- Ensured timely completion of validation activities by effectively managing project timelines and resources.
- Facilitated knowledge transfer within the organization through regular presentations, trainings, and written reports on validation best practices.
- Achieved successful outcomes in validation projects by fostering an environment of collaboration, open communication, and continuous learning.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Produced and maintained technical documentation for project reference.
Research Scientist
Wyeth-Lederle
01.1991 - 01.2001
- Performed assay development, clinical and pre-clinical testing (including live animal research) analysis on various pediatric and adult vaccines
- Identified opportunities for innovation by staying abreast of emerging trends in the scientific community.
- Contributed significantly to breakthrough discoveries through expert data analysis and interpretation skills.
- Evaluated new technologies for potential integration into existing research processes, driving continuous improvement efforts.
- Designed experiments using sophisticated statistical techniques, yielding robust results that supported key hypotheses.
- Documented and reported test results after making graphical solutions and representations.
- Worked as member of integrated project team in highly collaborative work environment.
- Conducted document review, organization and quality control of data acquisition to draw relevant conclusions and direct research activities.
- Performed accurate quantitative analysis of targeted data research, collection and report preparation.
Education
Bachelor of Science - Biology
Mercyhurst University
Erie, PABachelor of Science - Chemistry
Mercyhurst University
Erie, PASkills
- Scientific Writing
- Protocol development
- Training and mentoring
- Multitasking Abilities
- Analytical Thinking
- Adaptability and Flexibility
- Excellent Communication
- Documentation requirements
- Teamwork and Collaboration
- Self Motivation
- Problem-solving abilities
- Team Collaboration
- Written Communication
- Interpersonal Skills
- Task Prioritization
- Organizational Skills
Certification
- Certified Registered Central Service Technician (CRCST), IAHCSMM, 474130, 04/2019
- Biological Safety Specialist, NAMSA, 01/13/2021
Affiliations
International Association of Healthcare Central Service Materiel Management (IAHCSMM), 04/2019, Present
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Sr. Study Director
HIGHPOWER Validation and Testing Services
12.2014 - Current
Validation Scientist
Ortho-Clinical Diagnostics
01.2011 - 01.2013
Research Scientist
Wyeth-Lederle
01.1991 - 01.2001
Bachelor of Science - Biology
Mercyhurst University
Bachelor of Science - Chemistry
Mercyhurst University
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