Quality Engineer Certified as Quality Auditor and Quality Engineer by ASQ. Over 14 years of combined experience in the Pharmaceutical and Medical Device Industry; 10 of which spent in the Biopharmaceutical industry, Quality, and Compliance Management. Demonstrated deftness in handling quality systems, regulatory and cGMP documents. Proven skills in technical writing, training, and completing thorough investigations and audits. Effective communicator exhibiting excellent relationship and leadership skills. Result-focused, positive attitude and highly honed analytical skills.
CATSWeb, SAP, LIMS, gLIMS, Infolinx, eDOC, Docspace, Trackwise, SAS, CATSWeb. Documentum, TRAC
Microsoft Office: Word, Excel, PowerPoint, Outlook
Senior Quality Engineer ........................................11/2015 to CurrentSIEMENSNEWARK, DE
Manage the CAPA (Corrective Action/ Preventive Action) Process for site (non-manufacturing groups).
Root Cause Investigation Trainer.
Train CAPA investigators.
Quality Management Approver for non-conformance investigations.
Quality Engineer04/2014 to 11/2015SIEMENSNEWARK, DE
Associate Engineer........................................04/2014 to 12/2014MERCKLANSDALE, PA
Associate Process Scientist......................................06/2010 to 05/2013JOHNSON & JOHNSONMALVERN, PA
Compliance Wire Reporter04/2004 to 06/2010Root Cause Analysis
Performed manufacturing procedures within a cGMP environment: performed aseptic subculture for cell culture operations, prepared bioreactors and harvest vessels for production, monitored cell growth.
Trained new associates.
Performed Environmental Monitoring and Quality Control.
Lead, Cell Culture Batch Record Review Team.
Review cGMP documentation for completeness and compliance.
Implemented program that standardized process and improved efficiency by:.
Generating Batch Record Compliance Checklist and tracking document which assisted department in timely submissions.
Trained other associates.
Located gaps in system and implemented process to close them.
Created DELTA-V electronic templates for trending of historical data needed for batch records submission to QA.
Templates standardized process and made it easier for other associates to complete data trending.
Produced instructional documents with visual aid that assisted associates in retrieving missing data from electronic software such as SCADA & DELTA-V.
Document Specialist .......................................01/2003GLAXOSMITHKLINEKING OF PRUSSIA, PA
Formatted electronic study documents (GLP & non-GLP, Protocols) and ensured compliance with document management regulations.
Maintained appropriate audit trail of submission document modules.
Collaborated with Study Directors and Publishers in Regulatory Operations on module status and compliance issues.
Created training documents for new hires.
Developed compliance Formatting Checklist for all studies in order to standardize process.
Chair and CoordinatorCAPA Review Board CARB
management that reviews CAPA for quality, and compliance with regulations.
CATSWeb system (non-conformance system) administrator.
Assist in validation efforts and system enhancement.
Responsible for overall administration of corrective/ preventative action (CAPA) system for CAI Glasgow Non-Manufacturing Organizations.
Educates appropriate company personnel in the objectives of the CAPA system, with emphasis on all steps necessary to identify issues, investigate, and carry out timely, thorough, and effective action to correct existing deficiencies and minimize or eliminate future occurrences.
Reviews CAPA requests to determine if a formal CAPA needs to be assigned.
Ensures that CAPAs are properly documented, entered into the CAPA database, and assigned to the appropriate recipients.
Reviews CAPA Action plan to assure that it properly addresses findings and root cause(s) in order to correct deficiencies and/or prevent recurrence.
Provides CAPA metrics for functional groups that assist management to evaluate process performance for their groups.
Communicates quality trends for key quality indicators through presentations and/or various reports to assist company management in decision-making process.
Participates and Contributes to the CAPA Change Control Board meetings.
Provide coaching and feedback to CAPA owners.
Conduct and author manufacturing deviation investigations.
Conduct root cause analysis.
Decide on appropriate corrective and preventative action per investigation.
Initiate and assign CAPAs in SAP, Quality Management System.
Lead deviation management meetings.
Assist in training new hires.
Provided quality and manufacturing support.
Ensure full compliance with all applicable procedures and regulations.
Performed and wrote investigations for atypical events / manufacturing deviations and environmental monitoring (EM) excursions.
Conducted root cause analysis and initiated / finalized Corrective & Preventive Actions (CAPAs) plans, resulting in completion / submission of 100% of documented investigations and CAPAs within the Trackwise Event tracking system to QA by due date and/or before batch disposition date.
Reviewed completed Batch Records for completeness and compliance.
Performed issuance and inventory (SAP) transactions, ensuring flawless manufacturing execution and accurate data.
Completed 350 Batch Records annually.
Revised Standard Operating Procedures (SOPs) and production Batch Records to accurately reflect current process.
Gathered data and wrote the Pre-culture and Cell Culture section of site's Annual Product Review (APR).
Designed and maintained department's SharePoint site.
Team Lead, Malvern Site's Balanced Scorecard (BSC)Team.
Created a cross-functional team.
Facilitated and Lead Team Meetings.
Created site's BSC metrics.
Designed and formatted SharePoint that hosts site's metrics.
Collaborated with site's management to determine what metrics will be tracked.
Created key metrics indicators; ensure formula and data were accurate and displayed correct data.
Gathered data and report metrics at site's management meetings monthly.
Served as Member of the Human Error Analysis Team - Quality Team.
Revised quality & human error metrics, analyzed data, and provided recommendations to Site management.
Conducted internal audits.
Performed statistical analysis on department's annual human errors, identifying trends; and compared to the Site's trend.
Analysis which aided in decision making on steps that reduced human errors.
Received Gold Encore Award for authoring and designing training materials for monthly safety and compliance (GMP) meetings.
Conduct GMP trainings to fulfill regulatory annual requirement.
Member of Scrap & Loss Team.
Revised Scrap SOP to harmonize with BIO network; trained biotechnicians & supervisors on new process.
Reviewed detail scrap report for department and contributed suggestions that minimized scrap by $400K.
Education and Training
Bachelor of Science: Chemistry & Biochemistry2001West Chester UniversityPAChemistry & Biochemistry
BSC, Cell Culture, coaching, Continuous Improvement, data collection, database, decision-making, decision making, designing, document management, documentation, Documentum, Editor, electronic software, functional, GMP, GLP, internal audits, inventory, Japanese 5, Team Lead, LIMS, materials, Meetings, Excel, Microsoft Office, Outlook, PowerPoint, SharePoint, Word, network, newsletter, Page, personnel, presentations, Project Lead, Protocols, Quality, Quality Management, QA, Quality Control, requirement, safety, SAP, SAS, SCADA, Six Sigma, SOP, statistical analysis, Technical Writing, Trainer, training materials, Training Material, trend, validation, Website Design, author