Baylee Sparks
Bloomington,IN
Summary
Results-driven quality control professional with a strong background in regulatory compliance, client collaboration, and GMP/GDP compliance. Experienced in executing stability studies and quality control analysis, while generating detailed reports and documentation. Committed to enhancing laboratory processes and ensuring product quality.
Overview
7
7
years of professional experience
Work History
Scientist, Quality Control
Novo Nordisk
Bloomington, IN
01.2024 - Current
- Develop, organize, and implement stability studies adhering to FDA, EU, and ICH guidelines.
- Utilize various laboratory management systems including LIMS, ELN, Empower3, TrackWise, and Maximo.
- Collaborate with clients to establish stability protocols, oversee stability timepoints, and issue CoAs.
- Generate stability summary reports and evaluate trending reports.
- Draft deviations, change controls, laboratory investigations, and CAPA documentation utilizing the TrackWise system.
- Execute quality control analysis encompassing aliquoting, protein concentration determination, pH evaluation, osmolality profiling, conductivity checks, appearance inspection, total organic carbon quantification, mRNA content assessment, and purity analysis.
- Utilize techniques such as pipetting, HPLC, UV-VIS, KF, TOC, pH, FTIR, and titration.
- Record laboratory data adhering to Good Documentation Practices.
- Execute data analysis in alignment with the established analytical method.
- Train fellow analysts in testing methods and techniques.
- Partner with analysts and management to address in-lab and out-of-lab challenges utilizing 5S and cLEAN methodologies.
- Maintained laboratory equipment to ensure compliance with safety standards.
- Participated in training sessions to enhance team knowledge and skills.
- Maintained accurate records of experimental protocols and results in accordance with regulatory requirements.
Associate Scientist, Quality Control
Catalent Pharma Solutions
Bloomington, Indiana
10.2021 - 01.2024
- Execute quality control analysis encompassing aliquoting, protein concentration determination, pH evaluation, osmolality profiling, conductivity checks, appearance inspection, total organic carbon quantification, mRNA content assessment, and purity analysis.
- Utilize techniques such as pipetting, HPLC, UV-VIS, KF, TOC, pH, FTIR, and titration.
- Record laboratory data adhering to Good Documentation Practices.
- Utilize various laboratory management systems, including LIMS, ELN, Empower3, TrackWise, and Maximo.
- Execute Method Validation Protocols and Stability Protocols.
- Collaborate with clients to establish stability protocols, oversee stability timepoints, and issue CoAs.
- Execute data analysis in alignment with the established analytical method.
- Train fellow analysts on testing methods and techniques.
- Conduct monthly audits on client-specific materials, including reference standards and critical reagents.
- Document deviations and laboratory investigations utilizing TrackWise system.
- Develop and launch an onboarding program for new hires, while also serving as a mentor and key point of contact.
- Partner with analysts and management to address in-lab and out-of-lab challenges utilizing 5S and cLEAN methodologies.
Analytical Chemist I
Midwest Compliance Laboratories
Terre Haute, Indiana
12.2020 - 09.2021
- Conduct analysis leveraging diverse laboratory equipment and procedures, incorporating Wet Chemistry, HPLC, UV-VIS, KF, FTIR, pH, and TLC.
- Formulate and implement method validation protocols.
- Record laboratory data adhering to Good Documentation Practices.
- Perform data analysis utilizing specified analytical techniques.
Research Assistant
Indiana State University
Terre Haute, Indiana
06.2019 - 12.2020
- Evaluate mass spectra of poison frog alkaloids and consolidate the alkaloids within an online database.
- Perform sample evaluations through GC/MS.
- Educate new hires on the operation of GC/MS and the online database
- Arrange and showcase findings at regional, state, and national conventions.
Education
Bachelor of Science - Chemistry
Indiana State University
Terre Haute, IN12-2020
Skills
- GMP/GDP compliance
- Stability studies production and implementation
- Laboratory management systems
- Quality control analysis
- Data analysis techniques
- Regulatory compliance
- Client collaboration
- Technical writing
- Overseeing personnel
Affiliations
Volunteer - Bloomington Human Society
Languages
English
Native/ Bilingual
French
Limited
Timeline
Scientist, Quality Control
Novo Nordisk
01.2024 - Current
Associate Scientist, Quality Control
Catalent Pharma Solutions
10.2021 - 01.2024
Analytical Chemist I
Midwest Compliance Laboratories
12.2020 - 09.2021
Research Assistant
Indiana State University
06.2019 - 12.2020
Bachelor of Science - Chemistry
Indiana State University