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 trail review, and maintenance reports• 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 software• 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• Created sampling protocols, equipment, and methods for GMP release of new raw materials in collaboration with safety, facilities and development departments• Qualified new lab management software for long term expansion and enhanced data integrity in standalone units• Sourced alternate vendors and part numbers to build a safety stock of critical lab supplies before the lab ran out due to pandemic supply chain disruptions

• 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• Determined suitability of existing methods and set testing specifications for new raw materials• Transitioned temperature monitoring system in storage units from USB dataloggers to remote continuous monitoring system

• 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