Chloe Wolff Email & Phone Number

Cincinnati, Ohio, United States

• Ensure quality and integrity of ECG and Imaging clinical trial data by following GCP guidelines
• Prepare and review Core Lab Data Management controlled documents for the creation and maintenance of clinical trial databases to regulatory and client specifications
• Perform validation testing on clinical databases and edit programs to meet client study start-up timelines and to ensure the proper data is collected for the duration of the clinical trial
• Effectively communicate with internal and external teams to reconcile, review, and transfer high quality clinical trial data to clients

• Managed department’s largest service contract covering 30+ analytical instruments following co-manager’s sudden departure and kept instruments in compliance including scheduling, assisting service technicians, audit.
• Reviewed certificates of analysis, reports of analysis, and stability reports to ensure valid data was reported to clients
• Administrator of 8 types of standalone instruments responsible for reconciling user accounts and collaborating with technical support and IT remote and on site
• Designed a custom workflow in an electronic documentation system for out of specification investigations as a core team subject matter expert
• Represented site on 3 documentation committees tasked with combining the best features to create a unified client experience across locations
• Successfully lead the entire department of 13 through the performance review process, including 5 first time participants

Cincinnati, OH

• Investigated and wrote reports for all out of specification raw material results, then updated procedures and training to prevent recurrence
• Grew raw material testing group to 3 analysts that maintained on-time delivery of materials to manufacturing and packaged up to 4 stability studies a month to meet client timelines
• Enhanced visibility, control and compliance of stability and reference standard inventories in the absence of a digital inventory system by repurposing input fields and designing data queries in a new asset management.
• Provided constructive feedback on a new finance system as part of a continuous improvement committee that lead to standardized instructions for purchase requisition entry and reduced invoice approval time
• Promptly investigated and concisely wrote up the multiple causes of an after-hours stability chamber deviation leading to quick client reassurance of no sample impact and 3 corrective actions to address the root causes
• Reviewed analytical data to enforce GMP documentation standards with new analysts

• Performed routine analytical and wet chemistry testing per cGMP protocols as lead raw materials analyst, often with rush turnaround times to keep production on schedule
• Created and executed validation documents, configured software for data integrity, wrote detailed SOPs, and trained analysts to use new Raman and FTIR instruments
• Qualified new storage and monitoring equipment, then inventoried and relocated 3,000+ samples to bring outsourced stability samples onsite for the first time
• Designed training program in new electronic document system to ensure all hands-on trainings are assigned per job function and are properly documented
• Established an inventory of critical lab supplies, built a safety stock, and initiated a monthly check to prevent future work stoppages
• Subject matter expert in the contents, capacity, and maintenance of 15+ controlled temperature storage units to ensure all samples maintained integrity through proper storage

• Trained in cGMP techniques for raw materials analysis and microbiological monitoring to support the manufacture of early phase pharmaceuticals - oligonucleotides and small molecules
• Reconciled locations, equipment and calibrations to bring an outdated asset management software back into compliance
• Designed and implemented an organization system still in use 6 years later that improved analyst efficiency and freezer performance after observing analysts struggling to find samples in the freezer

• Recruited back to Hair Care R&D Team to manage product stability studies, developing methods to test the efficacy of prototype shampoo formulations, and execute batches at bench and pilot plant scale

• Taught elementary school science classes in English and improved Spanish speaking and comprehension skills while living in a foreign country for the first time

• Produced prototype formulations and evaluated their performance to identify new specialty raw materials for several shampoo brands as part of Hair Care R&D Team

• Researched detection of short-lived reaction intermediates using new ambient ionization technique for mass spectrometry and edited draft research papers for international students

• Maintained a safe and productive lab environment for undergraduates to reinforce general chemistry concepts through practical application