Highly motivated Pharmaceutical/Biotechnology professional who has accomplished multiple disciplines of the industry, which includes Planned, managed, and purchased all raw materials and consumables for specific Fermentation and Cell Culture projects. Managed Assay Qualification / Validation / Stability Studies to project completion of several phase II/III clinical drug development programs Transferred Stability Studies from Pearl River, New York to RTP, NC. Skilled and proficient with using MS Project, Excel, Visio, Powerpoint, JUMP, MiniTab, LIMS. Achievements Include: Received 2004 President's Achieving Excellence Award by identifying major trends in stability and mfg. data of seroptypes for Prevnar. Also supported corrective actions to alleviate trends. This saved the company millions of dollars of potential product loss. Cost saving initiative at Abbott Labs to eliminate endotoxin testing of all plant water Stills. Assisted with a cost savings initiative to convert all Pyrogen testing at Abbott Labs to LAL testing.

Supply Chain Coordinator @ November 2011 – Present Order and maintain project inventories for Raw Materials and Consumables. Communicate with vendors when issues arise with orders and try to resolve. Decrement materials from SAP to support manufacturing. Initiate MPRs in SAP to support specific projects. Revise Item Specification Reports for Raw Materials. Communicate with QC Raw Materials and QA on timelines for all raw material testing and release for assigned projects. Communicate with Technical Operations and CPLs on raw material/consumable orders, inventories, and material options to support fermentation projects. Review all assigned project upstream and downstream batch records and new raw material / consumable item specifications.  Perform a Cost Analysis for CPL’s on all raw materials and consumables used for assigned fermentation projects. From November 2011 to Present (4 years 1 month) Fujifilm Diosynth BiotechnologiesQA Technical Specialist @ Review all Analytical QC batch records and raw material data, and make sure corrections and comments are addressed with the assigned timeframe. Review all Analytical Test Methods, Assay Technical Transfer Protocols/Summary Reports, Assay Qualification/Validation Protocols and Summary Reports. Address questions between the Client and Authors, as well as manage approvals on protocols and reports. Provide assistance in stability pulls, shipping samples to clients. and other laboratories for third party testing. Manage stability inventories. Review stability protocold and provide comments to internal and external clients. From May 2010 to November 2011 (1 year 7 months) Fujifilm DiosynthAnalytical Core Team Member @ Managed Analytical Development and QC testing of client specific projects, which encompassed the following responsibilities:  Communicated project timelines and budget to line management.  Monitored functional activities to project budget and project timelines.  Provided analytical and stability hourly estimates.  Acted as a primary analytical group contact to client.  Escalated critical work-stream issues.  Communicated functional status to core team.  Communicated with the client during meetings and on-site/off-site visits.  Outsourced third party testing.  Created and managed manufacturing sampling plans for client specific projects.  Managed stability –related activities, as necessary, such as protocol management and sample submission. From June 2007 to April 2010 (2 years 11 months) QA STABILITY SPECIALIST III @ Managed Analytical Development Stability Studies in RTP/Sanford. § Authored VDLIMS Design Plans and entered Stability studies into LIMS to support the Analytical Development Lab. § Reviewed and approved data in VDLIMS. § Initiated and managed change control requests to support: ◊ the relocation of stability samples. ◊ the relocation of reach-in refrigerators, incubators, and freezers. the validation of two thermocycling units, photostability unit, and walk-in refrigerator /freezers. Managed the stability monthly IMR. Managed the Stability Monthly Pull List. Pulled and delivered stability samples to the Analytical Testing Laboratory. Shipped stability samples to other testing sites. Revised and authored stability protocols and other documents using GxPharma. Performed statistical analysis on stability data using JMP Software. Authored Analytical Development Stability Study Reports, identified trends and atypical results observed in stability studies. Presented stability updates to upper management using Power Point. Authored photostability chamber SOP, as well as the user requirements. Authored investigations to support excursions that occurred in the Stability Department. Trained other Stability Specialist to perform Stability functions. From October 2004 to June 2007 (2 years 9 months) QA/STABILITY PROCESS MONITORING SPECIALIST III @ §Supported the implementation of the stability information management (SLIM): Assisted with populating the system with studies and historical data. §Authored Stability Quarterly Monitoring Reports (SQMR) and Annual Stability Product Review Reports for assigned products. §Performed Process Monitoring Request Reports for assigned products. §Supported validation activities with stability studies. Validation activities included the following:à Assisted with new container/closure studies to support HibTITER® Single Dose Vaccines. This involved forecasting stability test schedules to QC Labs for HibTITER® container/closure studies (Pearl River, NY, and Abbott-McPherson, Kansas) to enable QC to identify resource needs. à Researched surrogate containers as a major cost-savings initiative.àAuthored stability protocol to support Seed Remediation Project .§Assisted with providing stability updates to Regulatory Affairs. §Revised Stability SOPs and Stability Protocols to comply with Level II Conformance Standards. §Participated on an investigational team to investigate the cause of process and stability data trends identified in a particular product. From March 2002 to October 2004 (2 years 8 months) QA ASSOCIATE I/II @ §Reviewed Activated Saccharide and Pneumococcal Conjugate Batch Records. Met with Manufacturing supervisors and/or operators to resolve any issues and/or errors found in batch records. §Coordinated with other QA Associates in performing monthly informal floor audits in the manufacturing area. §Assisted in media fill audits. §Coordinated, scheduled, and served as a facilitator of Standardization of Batch Review Checklist Team. Assisted in revising the Product Batch Records. §Sole reviewer of all product line P-12’s (QC product testing data). Created an Access Database for tracking P-12s in QA; and created an error tracking system, which was used to generate a monthly QC error reports. §Trained other QA Associates to perform QA functions. From October 2000 to May 2002 (1 year 8 months) QUALITY ASSURANCE SPECIALIST I FOR LARGE VOLUME SOLUTIONS @ -Trained with QA Supervisors in Large Volume QA - Management Trainee Program in Quality Assurance. -Audited and monitored incoming work order documents. -Performed inspections on finished products, as well as quality control checks. Also, performed internal audits in all Large Volume Production areas. -Investigated and authored Out-Of-Calibration Reports. -Performed monthly inspection light checks. -Answered any questions pertaining to quality issues that occurred on the production lines. From September 1998 to October 2000 (2 years 2 months) LABORATORY TECHNICIAN @ -Performed LAL and Heparin Potency Testing on Small Volume, Large Volume product lines and IV bags. Also, performed general lab duties. -Worked with special project and protocols in the lab which included: -Cost savings from the elimination of LAL Testing of Plant water stills. -Cost saving from converting Pyrogen Testing to LAL Testing. -Evaluation of LAL Testing vs. Kinetic/Chromagenic Testing. From September 1995 to September 1998 (3 years 1 month)

Courses in Microbiology, Ethics, and Bioinformatics, Biotechnology @ UMUC From 2004 to 2006 BS, Biology @ North Carolina Wesleyan College From 1990 to 1995 Kim Batts is skilled in: Microbiology, Fermentation, Testing, GMP, Biopharmaceuticals, LIMS, 21 CFR Part 11, Biotechnology, GLP, Change Control, Sop, Pharmaceutical Industry, CAPA, Formulation, Quality Control, Regulatory Affairs, Vaccines, Validation, Analytical Chemistry, Aseptic Processing, FDA, Laboratory, Quality System, Quality Assurance, SOP