SUMMARY:

• Quality Assurance Professional with over 16 years of expertise in the Biotech, Pharmaceutical and Medical Device industry. Knowledgeable in Good Manufacturing Practice regulatory guidelines which supports ability to manage and/or develop a Quality System infrastructure. ASQ Certified as a Quality Auditor.
• Experience in such areas but not limited to; Auditing, Drug Delivery for Unlabeled Drug Product and Investigational Medicinal Product, Packaging and Labeling, Fill Finish, Bulk Manufacturing, Supply Chain, Project Management, Operations Management, Regulatory Documents (CMC), Validation, Risk Management, Deviation Management, Corrective/Preventative Actions Management, and Change Management.
• An independent thinker who effectively utilizes interpersonal and analytical competencies to successfully overcome the challenges of cross - departmental communications, while effectively working with project teams to meet project deliverables.
• Highly focused on organizational missions while positively impacting bottom line and group performance.
• A professional with exceptional technical expertise, possessing an extensive knowledge of the processes, procedures, and policies necessary to consistently produce superior product and service.
• Able to remain calm and work well in high-pressure situations, constantly seeking new challenges, a driven individual with both strong work ethic and the desire to exceed expectations.
• Always on schedule and able to prioritize and handle multiple tasks with a sense of pride while achieving goals.

TECHNICAL SKILLS:

• Microsoft Office (Word
• Excel
• Project
• Visio
• PowerPoint
• Outlook)
• SAP - Enterprise Resource Planning (ERP) System
• Quality Information Management System
• Supply Chain Management System
• Quality Agreement Management System
• Document Management System
• Learning Management System

PROFESSIONAL EXPERIENCE:

Confidential, Philadelphia, PA

Quality Engineer

Responsibilities:

• Site implementation lead of corporate initiative to achieve data integrity compliancy for the PA site
• Lead the PA site in adherence to the Pharmaceutical Quality System requirements
• Manage product quality issues affecting distributed product that have potential to result in an In-Market action as recall administrator
• Provide support for site inspection readiness and change management
• Serve as a member of the Quality Council preparing and presenting KPI metrics to site leadership team for review

Quality Assurance Advisor

Responsibilities:

• Manage oversight for drug delivery of unlabeled drug product and investigational medicinal product to clinical sites in United States, European Union, Canada, Japan and Rest of the World for 25 projects
• Manage oversight for packaging and labeling activities for unlabeled drug product and investigational medicinal product to support on time drug delivery
• Lead cross-functional initiatives to ensure end-to-end deliverables according to established timelines
• Lead process improvement initiatives, to interpret, improve, implement and manage upgrades for quality procedures/systems
• Work independently or within a team structure, make decisions, solve problems, plan, organize and prioritize work
• Communicate issues, set priorities, and establish measures to ensure departmental expectations are met
• Develop processes and established quality assurance methodologies/standards
• Build working relationships across business departments, sites and 3rd party affiliates

Quality Assurance Specialist IV

Responsibilities:

• Drug delivery of unlabeled drug product and investigational medicinal product for multiple projects
• Create, implement and manage product specification file and work closely with the EU Qualified Person for Lot Release Activities
• Manage cross-functional teams including but not limited to Logistics and Clinical Supply, Regulatory, Analytical Testing, Manufacturing, Fill Finish sites, Packaging and Labeling sites and third parties to coordinate timely execution of deliverables
• Provide input and ideas during process improvements
• Work with internal and external business partners to ensure policies and procedures are followed
• Facilitate and coordinate regular meetings to ensure timely release of unlabeled drug product and investigational medicinal product
• Track and review weekly lot release activities to support metrics reports for Quality department
• Lead and/or initiate investigations for nonconformance’s and corrective/preventative actions
• Conduct audits including audit preparation, audit schedule, lead exit meeting, report issuance and approve/follow-up with corrective actions for internal and external audits
• Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, following up on action items.
• Routinely revised department standard operating procedures
• Single handedly delivered nonconformance training across the organization
• Effectively defended the Lot Release system during internal/ external audits (Contractor, Corporate, Mock)

Quality Assurance Specialist IV

Responsibilities:

• Responsible for the release of bulk drug substance to fill finish site
• Responsible for tracking and reporting weekly quality management systems metrics
• Participate in investigations and corrective action implementation
• Responsible for change management system using TrackWise. (TrackWise Subject Matter Expert)
• Responsible for facilitating weekly change review board meetings relating to validation activities
• Responsible for Quality support during the execution of manufacturing processes
• Responsible for reviewing and approving new and/or executed controlled document but not limited to validation protocols, production batch records, standard operating procedures, using Aegis
• Responsible for instructing monthly training courses for deviation and corrective/preventative action initiation, monitoring and reporting utilizing TrackWise system
• Monitored policies, processes, procedures and controls ensuring performance and quality of products manufactured
• Provided guidance and support to all GMP-related business partners at the site concerning compliance with relevant quality and regulatory policies and the development of strategies to improve quality working practices and system
• Conducted audits including audit preparation, audit schedule, lead exit meeting, report issuance and approve/follow-up with corrective actions for internal and external audits
• Serve as scribe during annual corporate audits

Pilot Production Supervisor

Responsibilities:

• Oversaw a team of 12 performing column chromatography, viral filtration, concentration/diafiltration and bulk filtration operations.
• Responsible for the accurate and timely completion of clinical manufacturing campaigns and review of associated documentation
• Responsible for tracking and ordering raw materials and process equipment for purification operations
• Coordinated all equipment service contracts and scheduled equipment calibrations
• Authored and/or reviewed master production records for accuracy and completeness
• Responsible for mentoring, growth and development of subordinates
• Prepared and delivered periodic annual performance evaluations including compensation to manage employee performance and development
• Responsible for hiring and training new employees

Associate Scientist I

Responsibilities:

• Performed all aspects of purification operations for the production of monoclonal antibodies produced in mammalian expression systems for investigational products
• Chromatography column packing and unpacking
• Operation of BPG 200, 300 and 450 column series, Millipore Isopak 630 column using Amersham Pharmacia chromatography skid with Unicorn software, Pall Corporation PK50 and PK300 chromatography skid with RSview software
• Clean in place, pressure test and steam in place tanks ranging in size from 375 L to 5000 L
• Produced buffers solutions for purification operations that require titrations
• Keep exact records according to current good manufacturing practices, including batch records, logbooks, and investigations
• Authored and/or edited standard operating procedures
• Created and completed change requests for standard operating procedures, master production records, and solution production records and validated systems using TrackWise