Held responsibility for small-volume parenterals, large-volume parenterals, terminal sterilization, formulation, and drug weigh. Investigated quality concerns for manufacturing and calibrations, ensuring implementation of effective and appropriate corrective and preventive actions. Worked closely with team to drive outstanding department commitments to lowest level on record, including zero exceptions, zero standard impact reviews, and 75% reduction in open CAPAs and protocols.  -Drove continuous improvement to process from raw materials to finished product.  -Closed 100% of investigations within 30 days, generating 99% CAPA closure on time without extension.

Oversaw premier product transfer from Clayton site to Vizag, India. Acted as manufacturing subject matter expert for multimillion-dollar product transfer project of product line to largest pharmaceutical facility in India. Provided direct hands-on instruction, remediation, and coordination for site start-up, ensuring seamless transfer of manufacturing process with minimal downtime to full-scale production. Contributed to development of new processes, including cold room filtration and single homogenization formulation. Improved process based on existing site knowledge to implement in new site. -Audited new manufacturing process and related documentation to comply with cGMPs, OSHA and FDA regulations, and ICH compliance.-Performed site audits of greenfield site for quality and safety-related activities.

Managed small-volume parenterals, large-volume parenterals, terminal sterilization, formulation, and drug weigh. Contributed to development of department to oversee internal and external commitments, internal and external audits, investigations, and improvements related to manufacturing at site. Served as external audit subject matter expert for manufacturing, interacting with regulatory agencies and completing formal responses for six agencies, including FDA, TGA, EMEA, PICS, CDSCO, and ANVISA. Developed manufacturing core team, consisting of cross-functional areas, to discover and remediate issues and events. Drove formulation event closures to three weeks from previous average of 45 days. -Acted as manufacturing lead to conduct facility-wide cross-contamination assessment and audit with outside firm. -Implemented mitigation, including short-term improvements and long-term facility modifications, resulting in zero observations on subsequent TGA inspection. -Investigated quality concerns and ensured implementation of appropriate corrective and preventive actions. -Served as manufacturing lead for formulation-related activities, managing team of four exempt employees, as well as monitoring projects, exceptions, CAPAs, and document revisions throughout group. -Contributed to corrective action and preventive action and change control board as department lead.  -Held responsibility for sterilizer replacement and validation, new product launch, product re-launch, process piping standardization and re-labeling, hose management implementation, and multiple cost-avoidance and cost-saving projects. -Updated cleaning procedure and clean room practices to industry standards, led WFI remediation, and managed drug weigh and dispense development. -Implemented lunch and learn for operators to increase base knowledge on equipment and processes, and led process improvement projects to decrease downtime, as well as increase throughput.

Directed terminal sterilization and stopper processing. Held responsibility for direct and indirect supervision of 16 individuals throughout four shifts, planning effective use of labor and materials, and meeting quality and production standards. Oversaw sterilization and processing of stoppers for Clayton site, ensuring prioritization of quality materials, products, and documentation by operators. Led CAPA management and completion for Manufacturing Department, serving as manufacturing Subject Matter Expert (SME) for change control procedures.  -Contributed to multiple quality initiatives, providing insight, performing batch record reformatting, and conducting tasks based on initiative requirements. -Managed multiple cross-functional projects, as well as manufacturing SME for internal and external audits.

Led small-volume parenterals manufacturing. Oversaw direct and indirect supervision of 28 individuals. Held responsibility for planning effective use of labor and materials, meeting quality and production standards. Investigated product quality concerns to determine root-cause, providing corrective and preventive actions, as well as implementing proper actions. Edited batch records to existing cGMPs, writing investigations and exception reports, as well as following through with CAPAs and effectiveness checks. Contributed to and led Lean initiatives to reduce waste, as well as increase productivity. Collected and compiled data for annual product quality reviews for 16 products.  -Provided cost-reduction plans to achieve savings for plant. Reduced inventory loss to plant by recognizing key defects and submitting strategies to overcome continuing issues. -Contributed to enhanced batch record team to improve flow, minimize potential errors, and reduce batch record review cycle time. -Managed time, employee reviews, coaching sessions, and disciplinary actions for employees.

Provided clinical services and management to over 30 offices, as well as 300 employees, within North Carolina and Virginia. Audited doctor and practice productivity for maximum profitability. Completed site audits for process improvement and revenue-generating practices. Conducted corporate continuing education for service and instrument-related issues.  -Created operational management and protocol procedures for doctors and staff.  -Maintained OSHA and HIPPA compliance within service areas.