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, implement, and oversee the Quality Management System to ensure regulatory compliance. Collaborates with Operations, Facilities, QA, and other site leadership to assess and mitigate risk.• 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.• Responsible for review and approval of analytical and in-vitro method validation reports, including Quality review of Empower and Analyst data. • Leads site inspection readiness initiatives which includes the internal auditing program. • Manages Quality System Elements including change management, deviations, CAPA, training, OOS/LIR.

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 journey mapping, corrective actions (CAPA), quality notification systems (OOS, NCR, and Complaints), standard work, audit processes, SOP development and product specifications. • 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%.• Developed Quality organizational structure to support plant conversion from a 2-shift (20-hour, 4 day) to 3-shift (24-hour, 5 day) work week.• Collaborated with site management team to rebrand the site’s Mission, Vision, and Guiding Principles aligned to the business unit’s growth strategy.

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 regulatory requirements as specified in 21 CFR parts 210, 211, 820 and ISO 13485. • 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 redesign, development of metrics, and divisional scorecards. Also supported site creation of World Class Organization (WCO) pillars for Improvement Methodology, Organizational Empowerment, Safety.• 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 system.• 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 outages since impacts and risks were proactively addressed. • 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 resulting zero overdue CAPAs.• 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 improving accessibility to completed training records. • 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 incoming raw material inspection area and mechanic workshop.

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.