Kristi Pittman Email and Phone Number

-Quality oversight for the critical systems unit., inclusive of validation, facilities, instrumentation, manufacturing maintenance and engineering.-Review calibrations and asset management in BMRAM.-Investigation support and approval for all quality functions.-Provide Protocol and report review and approvals.-Assist with change control management.-Assist with batch record review and incoming material release.

• Performed stability study management which included stability chamber management, along with sample pulls and receipts and inventory within SQL*LIMS, also created and approved stability studies within SQL*LIMS.• Scheduled all stability testing to ensure that samples were analyzed within specified due dates.• Executed stability testing utilizing UPLC, HPLC, UHPLC, and GC with Empower 2 software.• Performed QA review of analytical methods, stability protocols and reports, and method validation protocols and reports for compliance and continuous improvement measures.• Performed Controlled Drug duties which included receiving, reconciling, and dispensing controlled substances as needed for all laboratories.• Created stability protocols and reports to assess expiration dating, along with performing stability investigations and deviations.

-Quality oversight for the critical systems unit., inclusive of validation, facilities, instrumentation, and engineering.-Review calibrations and asset management in BMRAM.-Investigation support and approval for all quality functions.-Provide Protocol and report review and approvals.-Assist with change control management.-Assist with batch record review and incoming material release.

• Performed stability study management which included stability chamber management, along with sample pulls and receipts and inventory within SQL*LIMS, also created and approved stability studies within SQL*LIMS.• Scheduled all stability testing to ensure that samples were analyzed within specified due dates.• Executed stability testing utilizing UPLC, HPLC, UHPLC, and GC with Empower 2 software.• Performed QA review of analytical methods, stability protocols and reports, and method validation protocols and reports for compliance and continuous improvement measures.• Performed Controlled Drug duties which included receiving, reconciling, and dispensing controlled substances as needed for all laboratories.• Created stability protocols and reports to assess expiration dating, along with performing stability investigations and deviations.

• Supervised 17 chemists within my group and performed all performance reviews, and worked on development plans• Responsible for assessing all laboratory data prior to release against release and stability specification and internal release action limits• Outside of commercial release and stability testing, primary focus within my group included cleaning validation and laboratory automation (TPW and Multidose)• Responsible for writing all investigations within my function, including CAPA’s and change controls• Substantial involvement with technical writing skills which included SOP and form revisions, Method/Monograph revisions, and Method Validation Protocols and Reports- knowledgeable of software including: LabWare Lims, TrackWise, and Empower

• Team Lead for a Finished Product Group with respects to efficiency, documentation, teamwork and investigative skills• Performed Method development and validation for over 13 products, including 2 cleaning validation methods.• Performed Development and Validation testing utilizing Tablet Processing Workstation (TPW), also performed all the maintenance on the TPW•Performed development activities on Multidose (automated dissolution) along with all maintenance activities• Experience in technical writing including investigations, SOP revisions, Form Revisions, Validation Protocols and Reports• Utilized instruments including UPLC, HPLC, GC, Dissolution, UV-Vis, TPW, and Multidose (automated dissolution) • Tests Performed include: Content Uniformity, Assay, Related Compounds, residual solvents, stability testing, LOD, Particle Size, Dissolution, TOC, and NIR• High Volume output for testing with low error rate• Acted as part of the QBS team which made corrections for the safety and quality workflow within the laboratory• Took part in the Efficiency Initiative Group, developing a method and program for developing lower level chemists• Has lead and assisted in the training of others within a workgroup with emphasis on efficiency, productivity, quality and teamwork• Assisted in troubleshooting and initial investigative work related to help drive resolutions for OOS and OOT.

I worked in the Cleaning Verification Group alongside Quality Control. Developed and validated methods for cleaning validation. Utilized instruments including HPLC, Karl Fisher, and TOC analysis.