Responsible for the performance and authoring of investigations related to Quality Events identified during routine operations in a cGMP 503B Outsourcing Facility.• Timely and accurate execution of quality event investigations in accordance with internal policies and procedures, in compliance with required cGMP• Gathering of information from internal and external sources including but not limited to personnel interviews, batch production reviews, analytical and manufacturing data analysis and trending, etc.• Use of effective analysis tools to identify root cause for all investigations• Performance of risk assessment and impact assessment of each quality event• Identification and implementation of corrective and preventative actions (CAPAs) to minimize the impact of incidents and potential for repeat incidents• Monitoring and analysis of investigation trends• Facilitation of effective communication and collaboration between Production and Quality Teams• Collaboration with company Regulatory Affairs personnel to ensure current understanding of all rules and regulations from applicable regulatory boards and committees (example: State Board of Pharmacy, FDA, USP guidelines and OSHA) pertaining to investigative writing and investigative approachAssist with quarterly metrics for internal and external customers. Author risk impact assessments.

Support Quality Assurance lifecycle management of commercial products and the Quality Management System including regulated documents, processes and products. Review, compile, track and trend information in support of monthly, quarterly, and annual reports. Administer the product complaint and adverse drug experiences programs. Manage the change control program for internal and external changes. Work cross functionally with Regulatory Affairs, Medical Affairs, and Planning/Development colleagues. Familiar with Microsoft Office Suite and MasterControl.

Support Quality Assurance activities, including issuance and review of regulated documents, ensure processes and products are in compliance with current SOPs, current Good Manufacturing Practices, and 21CFR 210/211; and provide Quality Assurance support for Internal Quality systems. Provide final QA review, approval, and release of executed batch record documentation for 503B compounded pharmaceuticals; contract manufactured product, and clinical trial material. Familiar with Microsoft Office suite, MasterControl, NuGenesis LIMS, QAD, and Vimachem SSM.

Responsible for auditing manufacturing batch records and related documentation ensuring compliance to SOPs, cGMPs, and 21CFR 210/211 for the market release of pharmaceutical injectable products.

Monitored aseptic processing in a GMP facility to maintain the safety and quality of pharmaceutical products.