Taylor Fuller Email & Phone Number

Holly Springs, Nc, Us

• Develops and maintains quality and compliance metrics to track the performance of ABM's Life Sciences accounts. • Conducts internal audits at client sites to ensure compliance with regulatory requirements and internal policies.• Author, owner, reviewer and approver of Veeva controlled documents including Deviations, Standard Operating Procedures, Work Instructions, Forms etc. • Provides quality oversight for quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate. • Ensures that all activities and related documentation for facilities, equipment, materials and processes follow applicable regulations, as well as client and ABM's requirements relating to Good Manufacturing Practices, Good Documentation Practices and Safety. • Supports and represents clients Quality Team during audits and inspections with regulatory agencies during on-site inspections.

Durham, North Carolina, United States

• Trainer for bioreactor and flocculation/clarification operations for new hires in upstream manufacturing department.• Produced clinical and commercial gene therapies for upstream manufacturing department by performing bioreactor setup, inoculation, transfection, harvest, flocculation, clarification and CEX chromatography operations. • Supported tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.• Authored and revised standard operating procedures, master batch records and job safety analyses for upstream manufacturing equipment and operations.• Reviewed and executed work orders utilizing computerized maintenance management system to ensure preventative maintenance and equipment calibrations are performed within expiry.• Contributed to manufacturing investigations and root cause analysis to assist in development of corrective and preventive action plans.• Interfaced with process automation systems and electronic business systems (e.g DeltaV, StarLIMS, Blue Mountain, QAD, PI Vision, Documentum D2).

Durham, North Carolina, United States

• Supported gene therapy manufacturing site startup by performed SAT IQ/OQ/PQ commissioning, qualification and validation protocols on upstream manufacturing equipment.• Supported external manufacturing operations in Baltimore, Maryland.• Completed Millipore Sigma’s M Lab training in Burlington, Massachusetts for CEX and TFF chromatography skids.• Collaborated with MFG, EHS and QA departments to develop the job safety analyses for upstream manufacturing equipment which identifies administrative and engineering safety controls to mitigate potential safety hazards. • Performed routine safety inspections as a member of the site's EHS Safety Committee to ensure designated areas present minimal safety hazards for personnel. Point of contact for upstream manufacturing department.• Site medical emergency response team member; certified in performing CPR/AED/First Aid.

Durham, North Carolina, United States

• Operated 20L - 15000L stainless bioreactors for cell culture (seed train) large scale manufacturing department. • Performed RCM and validation protocols for bioreactors, media tanks and filter transfer station. • Performed CIP, SIP and pressure tests for bioreactors, media tanks and filter transfer station.• Revised key documentation including master batch records, solution lot records and equipment logbooks.• Interfaced with process automation systems and electronic business systems (e.g., DeltaV, LIMS, Blue Mountain, InfoBatch, Kneat, MyQUMAS, Syncade, DevonWay).• Executed equipment logbook requests to Quality Assurance and reviewed equipment logbooks.• Documented, recorded and reviewed cGMP data and information (including documentation of deviations) for processing steps and equipment activities, following standard operating procedures.

Holly Springs, North Carolina, United States

• Performed AQL inspections of finished drug product for Fill Finish manufacturing department.• Operated WAVE, stainless and SUB bioreactors for upstream manufacturing department.• Responsible for assembly, set-up, and disassembly of upstream manufacturing equipment.• Interfaced with process automation systems and electronic business systems (e.g., DeltaV, LIMS, SAP, Atlas).