Rebecca Mitchell
Grand Rapids,MI
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
8
8
years of professional experience
Work History
Quality Control Lead Scientist/Manager
Empirical Bioscience (Fortis Life Sciences)
08.2021 - Current
- Managed laboratory operations including budgeting, project management, people management, and KPIs.
- Established clear communication channels between departments to facilitate timely resolution of quality concerns.
- Reduced waste by conducting root cause analysis on defective products and implementing corrective actions.
- Ensured compliance with ISO 13485 regulations and company standards through regular internal and external audits of processes and systems.
- Collaborated with production teams to address and resolve identified issues, reducing overall rejection rates.
- Provided technical support to other departments regarding product specifications and customer requirements, fostering a collaborative work environment.
- Cultivated strong relationships with key stakeholders both internally and externally to foster open lines of communication around product quality.
- Monitored product quality at all stages of production process.
- Investigated customer complaints to take necessary corrective actions.
Manufacturing Scientist
Empirical Bioscience
08.2018 - 08.2021
- Recombinant protein purifications (chromatography, nickel bead/gravity columns, HPLC, etc.)
- Master mix formulation and dispensing
- Quality control using qPCR, PCR, RT-qPCR, restriction enzyme digest, bioanalyzers, SDS-PAGE, etc.
- Product stability studies using accelerated aging
- Maintained accurate records of all methods and research conducted and wrote in-depth records.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Conducted experiments in laboratory environment for product development purposes.
Instructional Graduate Assistant
Grand Valley State University
08.2017 - 05.2018
- Administered coursework, graded assignments and provided constructive feedback.
- Provided tutoring support to students requiring additional assistance in subject matter comprehension and skill development.
- Supported course instruction through leading breakout sessions, group discussions, and supplementary lessons designed to reinforce key concepts.
- Preparation of reagents and other laboratory supplies for classroom experiments
Research and Clinical Intern
NxGen MDx
05.2017 - 08.2017
- Assisted in the execution of various diagnostic tests.
- Assisted in the development and implementation of a new diagnostics assay to evaluate patient genetic carrier status.
- Managed patient blood and DNA storage using databases
- Laboratory and instrument maintenance
Research Assistant
Khoo Laboratory/Grand Valley State University
05.2016 - 05.2017
- Investigated microRNA expression as it relates to Parkinson's Disease progression primarily using RT-qPCR.
- Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
- Mentored junior researchers, promoting professional growth and skill development within the team.
- Organized research materials, maintaining a well-ordered workspace conducive to productivity.
- Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
- Performed statistical, qualitative, and quantitative analysis.
Education
Master of Science - Biotechnology
Grand Valley State University
Grand Rapids, MI05.2018
Bachelor of Science - Molecular Diagnostics
Ferris State University
Big Rapids, MI05.2016
Skills
- ISO 13485 Standards and Auditing
- Quality Systems Management
- Project Management
- Quality Control/Product testing
- Good Manufacturing Practices
- Validation studies
- Stability Studies
- ERP Implementation and use (D365)
- Continuous Improvement
- Risk Assessment
- Supplier Quality Management
- Customer Focus
Timeline
Quality Control Lead Scientist/Manager
Empirical Bioscience (Fortis Life Sciences)
08.2021 - Current
Manufacturing Scientist
Empirical Bioscience
08.2018 - 08.2021
Instructional Graduate Assistant
Grand Valley State University
08.2017 - 05.2018
Research and Clinical Intern
NxGen MDx
05.2017 - 08.2017
Research Assistant
Khoo Laboratory/Grand Valley State University
05.2016 - 05.2017
Master of Science - Biotechnology
Grand Valley State University
Bachelor of Science - Molecular Diagnostics
Ferris State University
Similar Profiles
Nicolina Lashoff (Clemente)Nicolina Lashoff (Clemente)
Manager, Technical Transfer at Fortis Life SciencesManager, Technical Transfer at Fortis Life Sciences
Shubhraman RoutShubhraman Rout
Senior Program Manager at Industry: Life Sciences, Crop Sciences & Consumer HealthSenior Program Manager at Industry: Life Sciences, Crop Sciences & Consumer Health
SHANMUGARAJ S BSHANMUGARAJ S B
Deputy Manager - Project Management at Lakshmi Life Sciences Private Limited -Unit 1Deputy Manager - Project Management at Lakshmi Life Sciences Private Limited -Unit 1