Arwen Sutton Email & Phone Number

Kankakee, Illinois, United States

Phoenix, Arizona, United States

• Senior QC Microbiology representative reporting to Senior Director, Quality Operations. Directed a department of 25+ personnel. Oversight included Aseptic Gowning and Qualification Program, Environmental Monitoring.
• Reorganized QC Microbiology Department to strengthen departmental capabilities, improve culture within department and provide more development and career opportunities for staff, leading to greater retention and.
• Drove successful implementation of electronic system for laboratory and environmental monitoring data.
• Decreased execution error rate in EM resulting from streamlining and simplifying EM program and documentation.
• Increased and improved department visibility across site by improving customer service model and partnering effectively with other departments onsite.

Canton, MA

• Senior QC Microbiology representative reporting to Director, Quality Control. Responsible for a team of six personnel. Oversight included Aseptic Gowning and Qualification Program, Environmental Monitoring (EM).
• Designed and managed execution of aseptic manufacturing area EM performance qualification, resulting in a robust, compliant and manageable routine EM program.
• Established routines for analysts to empower them to adjust their test schedules as needed while achieving department goals for right first time and on-time paperwork.
• Participated in inspections with regulatory agencies and corporate quality as a microbiology, sterility assurance and quality expert.
• Designed and managed trending of environmental monitoring and test data, and used the data to drive continuous improvement initiatives.
• Standardized paperwork flow to maintain control and timeliness of product release.

Bedford, Ohio, United States

• Oversaw executing method suitability testing for bioburden, bacterial endotoxins and sterility testing for a multi-product aseptic manufacturing facility, designing and performing EM trend reports, department and site.
• Revised the investigation procedures to streamline the investigative process. Designed effective ways to present the findings of the investigations for multiple audiences, such as corporate colleagues, manufacturing.
• Participated in Gap Assessment and Remediation activities in a Consent Decree environment.
• Participated in site decommissioning, including evaluation of laboratory assets, identification of equipment and systems requiring GxP decommissioning and ensuring compliant technical transfer of test methods for.
• Participated in multiple customer audits as a subject matter expert in various procedures and disciplines, as well as GMP and PAI inspections by regulatory agencies and corporate partners. Explained current procedures.

Syracuse, New York, United States

Handled routine laboratory and utility testing and EM, supporting and standing in for QC Microbiology Manager as needed, scheduling EM and lab tasks for five manufacturing lines across two facilities and review of laboratory documentation, designing and authoring EM trend reports, department and site investigations, CAPAs and Change Initiatives and.

B.S, Biology

A.S, Math/Science

Activities and Societies: Phi Theta Kappa

A.A, Humanities

Activities and Societies: Phi Theta Kappa