Bethany Mcdaniel (Daly) Email & Phone Number

Responsible for assisting in the establishment and maintenance of all site level Quality Systems and for recommending and overseeing improvements when needed. Primary Administrator for the site’s electronic Quality Systems used for the management of GMP Documents, Product Complaints, Deviations, CAPAs, Change Controls, and Training. Responsible for administering the site’s Management Review Process, which includes the tracking, trending, and reporting of all Quality Systems metrics and key performance indicators on a periodic basis. Serve as the site’s Administrator and representative for all electronic Quality Management Systems (MasterControl, Veeva QualityDocs, ComplianceWire, Trackwise Digital) Review Global policies against site SOP’s to implement and drive changes to site SOP’s as required. Site representative during FDA Inspections associated with Quality Systems. Monitor quality system metrics and identify changes needed to improve Quality Systems and existing software applications as necessary. Maintain Training Curricula for all site personnel and ensure the site remains compliant with all required training.

•Ensure Quality Assurance is maintained during manufacturing and facility operations•Assign lot numbers and expiry dates to Clinical and Commercial drug products and subassemblies•Develop and support implementation of improved business processes including creating and revising SOPs.•Implemented electronic document management program using MasterControl•Perform System Administrative duties for MasterControl document management system•Support Document Management program and activities through MasterControl•Provide user support and training for MasterControl•Provide support for regulatory inspections or filings•Oversee training document filing and storage.•Responsible for preparation of training documents and verification of training completion•Implemented complete Product Complaint processing program from initial intake of complaint through final close out with the complainant•Manage product complaint program including customer service, product replacement/reimbursement, and product return.•Track/trend product complaints •File Field Alert Reports to the FDA as needed•Perform Customer Complaint investigations including batch record review and return sample examination, and ensure timely close out•Support vendor/supplier qualification and acceptance program•Support Internal/External audit program including our GMP manufacturing facility, supplies/vendors, and contract manufacturers•Support CE Mark activities and programs•Support Manufacturing and QA Operations by performing Line Clearance, in-process sampling, and environmental monitoring activities as needed.•Authored various SOPs, Work Instructions, and audit reports