Penelope Wagner Email & Phone Number

Chapel Hill, NC, US

Durham, NC

• Leads Quality Assurance team for Clinical Research Organization (CRO) which focuses on formulation development and pre-clinical to clinical manufacturing of dermatological pharmaceuticals. Responsible to develop.
• Ensures corrective and preventative actions are implemented to prevent recurrence of quality issues.
• Implemented process for handling and tracking of audit observations to assure timely closure.
• Hosts quality system, regulatory, and client audits. Responsible for audit responses and managing associated corrective action plans.
• Addresses adverse trends and patterns found while tracking and trending Quality System Indicators.
• Manages process for document development, handling, storage and archival.

Raleigh-Durham, North Carolina Area

• Guided regulatory compliance of Natural Cosmetic Manufacturing site through hands-on management of the elements of the Quality Management System (QMS). Including management of Quality team (23 employees), facility.
• Spearheaded initiative to convert site quality team to “flex to the work” model which increased responsiveness to operational issues and resulted in less machine downtime.
• Championed initiative to build cross functional partnerships within Burt’s plant to maximize quality influence and impact resulting in an improved quality culture at the site.
• Orchestrated creation of product specific laboratory testing forms which saved 1560 hours annually (38%) by eliminating redundant work.
• Supported successful launch of 20+ innovation projects this calendar year in fast past work environment while meeting or exceeding business goals.
• Prepared yearly departmental budgets, including funds for staffing and outside services. Utilized cost saving opportunities to reduce consumable lab testing supplies while product volume increased by 30%.

Meriden, CT

• Led Quality department (16 employees) for sterile topical over-the-counter (OTC) drug and device manufacturing facility for domestic and international distribution. Ensured Quality Management System (QMS) met.
• Integrated site’s quality systems with the Clorox Company after 2012 merger. This transition included building effective relationships with corporate partners, clarity of roles and responsibilities, organizational.
• Assembled, trained and led auditee team to ensure site readiness for FDA/ ISO/ customer audits. Team supported 6 – 8 audits annually. Responded to auditor with corrective action plan to address and improve the quality.
• Successfully redesigned change management process to improve ease of use while increasing cross functional ownership and accountability. Increased utilization of change management process resulted in less quality.
• Coordinated and conducted on-site supplier audits to minimize risk of quality related supply outages.
• Created and co-presented “Path of Contamination” training workshop to 100 employees to demonstrate how they impact and can help prevent product contamination.

Meriden, Connecticut

• Handled quality assurance activities related to Corrective and Preventative Action (CAPA) processes. Analyzed plant metrics and Quality System trending to proactively communicate the facilities quality risk areas.
• Expanded site CAPA program to reduce quality risks, and improve regulatory compliance.
• Developed, and maintained employee resource allocation tool to ensure level distribution of CAPA projects throughout the organization while monitoring real-time resource constraints.
• Founded cross function management CAPA Board meetings to escalate project outages and address resource constraints before compliance issues arose. Within the 1st year the CAPA closure rate was significantly improved.
• Spearheaded CAPA project to implement MasterControl Training Module enabling transition from paper based to automated electronic training records. Efforts resulted in a significant reduction in recordkeeping time while.
• Gained necessary skills through self-motivated online training to obtain ASQ Certified Quality Engineer certification after Quality department skill gap was identified by management.

Meriden, CT

• Guided team of (9) quality control personnel working across (3) shifts. Areas of oversite included in-process, final, and incoming raw material inspection processes in FDA regulated manufacturing facility.
• Hired, trained, and managed performance of QC inspection personnel.
• Planned and coordinated annual process validations and production equipment calibrations without interruption to production schedule.
• Promoted lean manufacturing tools and techniques through training and coaching of personnel including run charts for quantity of inspection defect, cases rework and reinspection, customer complaints closeout, 5-S of.

Meriden, Connecticut, United States

Guided various teams of quality personnel working across (3) shifts. Areas of oversite included in-process, final, and incoming raw material inspection and laboratory processes in FDA regulated manufacturing facility.