PERFORMANCE PROFILE
• Highly skilled Quality conscious professional with demonstrated success in FDA, USDA, EU regulated environments including GMP manufacturing, pharmaceutical research, and medical devices with proficiency in a variety of software packages including SAP, LiveLink, Documentum, and various LIMS systems.
• Contributed to the continuous improvement of a corporate quality system with the goal of providing consistent, high quality products and services to the customers with complete, accurate documentation.
• Initiated the implementation of a stability studies laboratory information management system that resulted in a department wide migration to a laboratory information management (LIMS) system.
PROFESSIONAL EXPERIENCE
Gen-Probe Inc., San Diego, CA 07/2010-Present
Quality Assurance Specialist III (Telecommuting from PA as of 1/18/2011)
• Create systems to streamline metrics compilation and dissemination using SAP, QlikView, PowerPoint, and Excel. Compiled, analyzed, and reported the weekly, monthly and quarterly metrics for the company as they related to CAPA and Nonconformances.
• Developed reference guides to train peers on performing the various types of metrics.
• Responds to ad-hoc queries from management and the audit team in support of providing data that was pertinent for FDA PIA inspections and a TUV audit.
• Assesses incoming Nonconformances for risk and completeness in an SAP system. Reviews investigations for OOS, OOT, and Level 1 for thoroughness and supporting documentation. Interacts with internal customers to align and resolve investigations to be acceptable for the interest of the company and in compliance with regulations. Routes approval of nonconformance investigations to affected departments for approval as well as provides the approval from the Quality department.
Lampire Biological Laboratories, Inc., Pipersville, PA 08/2003-07/2010
Quality Assurance Compliance Manager
• Maintains FDA Quality System Requirements for Medical Device and Human Blood Establishments for the company and routinely interacts with client, state, federal and local regulatory and licensing authorities as needed.
• Participates in internal, client and regulatory agency audits. (FDA(EC), USDA, AAALAC, NIH-OLAW)
• Created and maintains a CAPA database and issued monthly reports. Verifies the corrective action of cited observations.
• Coordinates and participates in elements of investigations regarding customer complaints. Responsible for periodic review, distribution, maintenance, withdrawal and archiving of quality records/SOPs.
• GMP contract manufacturing responsibilities include the review, reconciliation, and distribution for use of all client provided controlled documents and SOPs for use within LBL for confidential products and service provided to those clients. Reviews and dispositions raw materials, labeling and critical component documentation used in manufacturing. Reviews and approves all completed product formulation and filling records, and testing data for approval to ship filled product to the customer.
Computer Applications Specialist/Consultant 10/2000-08/2003
• Write SOPs and other Quality Assurance Documents.
• Create and design reports, tables, forms and design overall database relationships using MS ACCESS.
• Design and create training materials for users, provide training to the users on new software procedures and applications. Maintain hardware and installation of software for 8 users.
Merck and Co., Inc, West Point, PA 08/1999-08/2000
Computers Application Specialist
• Implementation of LIMS, including the development and optimization of a key operating system for the BBR department through working with computer support personnel.
• Development of a knowledge base of related concepts and documents from external agencies and outside sources as well as those required internally.
• Enhance intra- and inter-divisional communication regarding related topics and policies. Contribute to the development of a release database to be used prior to the implementation of LIMS. Additionally, provide support for the BBR Release database through establishing user accounts, maintaining and enhancing web based reports.
• Provide computer support to the department through maintaining and enhancing the BBR website, acting as a back-up administrator for the issuance of new computers and related services.
Merck and Co., Inc (continued)
Stability Analyst 07/1997-08/1999
• Provide protocol initiation and implementation for both ongoing and new stability studies and RM/CM release support.
• Forecast upcoming sample submissions to the testing labs, and provide samples to analytical labs.
• Assist Operation’s Group personnel with tracking, entering, verification, and approval of data entered into SLIMs, as well as the analysis of data through SLIMSTAT.
• Collaborate with other Operation’s Group personnel to generate and maintain consistent stability policies throughout BBR.
GMP Compliance Auditor 09/1996-06/1997
• Audited supportive data for new products under the current Good Manufacturing Practice (cGMP) regulations.
• Reviewed written audit comments with personnel directly responsible for the content of the report, resolves all findings and coordinates the revision to the appropriate reports.
• Audited research and development departments to assure that the practices, procedures, records, facilities, and personnel are in conformance with cGMP regulations.
• Contributed to the development of appropriate cGMP procedures for areas within research and development.
RELEVANT EXPERIENCES
Greater Philadelphia Health Assembly, Philadelphia, PA 08/1995-09/1997
Computer Consultant -Maintenance and modification of the membership database and coordinatio...
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