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
swipe to browse
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
- Certified Registered Central Service Technician (CRCST), IAHCSMM, 474130, 04/2019
- Biological Safety Specialist, NAMSA, 01/13/2021
Similar Profiles
PHILOPATEER SAMUELPHILOPATEER SAMUEL
Gandalf's Bank - Desktop Banking App at For Software Testing and Validation CourseGandalf's Bank - Desktop Banking App at For Software Testing and Validation Course
Josh FennJosh Fenn
Validation Engineer at New Zealand Validation ServicesValidation Engineer at New Zealand Validation Services
Maya SchneidermanMaya Schneiderman
Recruiting and HR Lead at Validation CloudRecruiting and HR Lead at Validation Cloud