Maria P. Email & Phone Number

Durham, North Carolina, United States

Program Manager for global biopharmaceutical projects including cell line development, process development, analytical development, and cGMP manufacturing. Provide leadership for cross- functional teams, create/track metrics, execute contract deliverables, and facilitate project meetings. Responsibilities include revenue forecasting, risk management, invoicing. Primary contact for management, partners, and clients.

Wilson North Carolina

 Provide Quality Assurance oversight of Manufacturing and Quality Control areas.  Provide QA review and approval of new and existing procedures, investigation documentation, and process controlDocuments. Use trend and investigational data to create value through process improvements and failure reduction activities. Identified failure modes and related process improvements, facilitating teams and working independently to Implement required changes. Perform as QA technical review for assigned area. Provides final QA approval on all process, cleaning, method validation protocols, reports and discrepancies, change controls, deviations, OOS investigations, complaint investigations, equipment/facilities.  Provides first response for Quality and Compliance issues on the manufacturing floor and the laboratories. Provides review and approval of: Deviations, Investigations, and Inquiries; Protocols/Discrepancies (Validation, Equipment, Process, and Production); Change Documentation (CCR’s, DCM’s); CAPA.  Uses data trends to work with operating departments to identify process improvement opportunities. Drives compliance, efficiency, or process improvement projects. Represents QA on cross functional improvement and process monitoring teams.  Leads and/or participates in scheduled and unscheduled audits of operational areas.  Lead teams for tracking of quality activities, metrics, CAPA tracking, and etc. Provide QA approval on any of the following: Change Control; Operational Procedures; Deviations; Lab Inquiries/OOS Investigations; Process, cleaning, validation protocols, reports and discrepancies; Process, equipment and facilities qualifications, protocols/reports; Monitoring instruments and procedures.

Toronto, Canada Area

 Generating and executing IOQ protocols for compounding equipment such Symex automated and non-automated 65L, 300L, 500L and 1000 L, for Estée Lauder for new over the counter (OTC) cosmetic products. Responsible for communications to management & other Units in Canada and USA.

Melville , Ny And Toronto, Canada

Addressing immediate corrective actions to FDA-483 observations. Provide Project Management and quality oversight to new and /or JR validation staff on identifying and understanding the resources need it to develop and execute protocols.Generating and executing IOQ and PQ protocols for compounding equipment, filling Lines, DI system for Estée Lauder and Estée Lauder R & D new over the counter (OTC) cosmetic product launch.

Raleigh-Durham, North Carolina Area

Experienced professional with extensive experience in a variety of technical positions: As CAPA Remediation, FDA Remediation's, investigations and deviations liaison, change control coordinator, auditor, validation project manager, validation project leader, and lab manager. Specific areas of expertise are in Quality Systems, CAPAs, Change Control, Deviations, validation of pharmaceutical, biopharmaceutical and medical device processes. With experienced in validation of aseptic processing, cleaning validation, process validation (PV), equipment qualification (IQ, OQ, PQ, PPQ, and line Integration Protocol (LIP), method validation, and laboratory operations. Comprehensive knowledge of: Current Good Manufacturing Practices (cGMP), and current Good Laboratory Practices (cGLP).

Marion Nc

CAPA REMEDIATION.➢ Performed the role and responsibilities as a CAPA Owner, CAPA Investigation Owner and CAPA Quality Reviewer as corrective actions for FDA 483 observations➢ Help in the reduction of Back log of CAPA’S open➢ Provide quality oversight with respect to investigations and coach Baxter personnel involved in writing CAPA’s with identifying, understanding the resources needed to develop and refine their behavior and skills.➢ Performs thorough reviews of the event and CAPA investigations and provide feedback to the department owners➢ Assesses criticality of major and critical deviations/event and CAPA investigations and provide technical support.➢ Track and report the status of the trend analysis of events, CAPAs to the department owners.

Fougera (Nycomed Us) Hicksville And Melville, Ny

Addressing immediate corrective actions to FDA-483 observations. Member of a team performing filling lines qualification assessments to evaluate the filling lines qualifications and supporting performance documentation associated with the lines against current FDA and Fougera pharmaceuticals (Nycomed US) equipment and process qualification/ validation standards in order to determine if requalification was advised. Including writing and executing engineering studies, IOQ qualification protocols, integrated filling /packaging line protocols and assessments.

Downingtown, Pa

Philadelphia, Pa

Charlotte, North Carolina, United States