Sarah Hurst Email & Phone Number

St Louis, Missouri, United States

As a Quality Services Customer Relations Manager, I oversee a large global strategic customer from a Quality, Regulatory and technical perspective. I partner with internal and external stakeholders to ensure we meet the needs of our customers. I am the voice of the customer when it comes to quality of our MilliporeSigma products.

Greater St. Louis Area

Primary responsibilities include, Customer Audit Coordinator for the Cherokee site, Customer Audit Host for the BioOrganics and BioBuffers manufacturing facilities, complying Annual Product Review Reports for commercial APIs, and Quality representative for 3 products manufactured in the BioOrganics facility. Responsibilities as Audit Coordinator include being the direct point of contact with customers and business partners to schedule routine Quality Audits. This includes determining the products, sites, facilities, and standards in scope of the audit. As Customer Audit Host, responsibilities include setting the audit agenda with the customer, coordinating audit activities with Management and the Manufacturing team, preparing necessary audit documentation and tours, communication to the site, and is main point of contact for the customer, Management, and Subject Matter Experts prior to, during, and after the audit. Support Quality and Manufacturing in daily activities to include: issuance and review of batch records, review and approval of Manufacturing documents and Quality Control data, release of finished goods, review and approval of site document updates, and review and approval of change controls impacting the manufacturing processes.

St. Louis

Provided support for the Quality systems necessary for the packaging of pharmaceuticals. Supported staff in daily activities to include: creation and approval of batch records, approval of inspection documentation, review of bulk Certificates of Analysis and temperature data, release of finished goods, and inventory investigations. Coordinated and documented all activities related to the following Quality Assurance systems: the stability program, annual product reviews, GMP training program, tracking and investigation of deviations, corrective and preventative action, and new product launches. Designee for the Quality Assurance Manager for the following responsibilities: review and approval of deviations and CAPA implementation, review and hierarchal approval for Change Control, approval of complaint investigations, and approval of trending reports. Recognized as “Up and Coming” employee within Sanofi Quality 2014.Managed successful 2017 FDA Inspection in Quality Assurance Manager’s absence. Led a team to reduce downtime between production runs and to increase efficiency on a high volume secondary packaging line in 2015.Part of New Product Launch Team to successfully release product within days of FDA approval.

Earth City, Mo

Provided technical, operational, and supervisorial support while also participating in daily sample preparation. Maintained primary focus on maximizing productivity and meeting client, state, and federal requirements on a daily basis including Quality Assurance, SOPs, DoE, and DoD. Promoted from Radiochemical Analyst to Radiochemical Supervisor.Facilitated individual performance reviews and participated in the recruitment, employment, and release of personnel in the department, resulting in a strong and knowledgeable team that worked efficiently to meet department needs. Created SOPs in regards to significant developments and trends in the field, resulting in better efficiency within the department.

Bachelor Of Science - Bs, Biology, General

Education record

Associate'S Degree, Biology, General