SUMMARY

• Accomplished Quality Assurance professional with over 16 years of experience in the Pharmaceutical, Biotechnology and Medical Device industries.
• Demonstrated business analysis ability with highly technical skill set in project management, implementation of business processes, IT solutions and all aspects of quality management systems, design control, manufacturing, and distribution.
• Highly collaborative, solution - oriented leader with the ability to analyze, evaluate, and resolve complicated, time-sensitive issues.

PROFESSIONAL EXPERIENCE

Confidential

Sr. Quality System Consultant

Responsibilities:

• Quality management program development and implementation
• Change Control Management oversight
• Good Document Practices (GDP)
• SOP and Validation Compliance
• Corrective Action Plan implementation and revision (CAPA)
• Laboratory Instrumentation qualification
• Training
• Quality Management Systems Integration
• Manufacturing process assessment and (re)qualification
• Root Cause Analysis: Manufacturing, Distribution, Complaint, Laboratory Investigation, Product Recall

Confidential, Shepherdsville, KY

Quality Assurance Specialist III

Responsibilities:

• Document repository (SharePoint/AZ-Doc) Integration Project Business Core Team member and site project lead.
• Outlined and submitted testability plan requirements for business unit.
• Assessed adequacy of system and subsystem testing activities, ensuring adherence to all site-specific needs and specifications.
• Provided technical assistance to program and project managers as required.
• Handled inquiries regarding requirements for both biologics distribution and quality management systems.
• Performed site documentation gap assessment to identify 21 CFR Part 11 and Part 820 status and deficiencies as well as critical SharePoint/AZ-Doc requirements.
• Lead for Quality Risk Management (QRM) business process rollout.
• Developed and implemented integrated site procedure and corresponding training materials.
• Developed and managed site Quality Risk Register.
• QA lead, reviewer, and approver on all cold room and shipping material qualification (IQ, OQ, PQ) documentation.

Confidential, Chicago, IL

Quality Analyst

Responsibilities:

• Reviewed and remediated Manufacturing Deviations and CAPAs to ensure adequacy, completeness of content (Containment, Problem Statement, Investigation, Root Cause, Risk Assessment, associated Action Plans, etc.), and compliance to 21 CFR Part 820.
• Lead investigations with the CAPA owner and coached team to properly identify root cause and implement adequate corrective action.
• Reduced Manufacturing Deviation and CAPA backlog.
• Reported weekly metrics, investigational bottlenecks and/or production anomalies to management and impacted Business Core Team units to foster increased communication across the functional areas.
• Provided CAPA coaching to ensure full implementation and understanding of improved investigation requirements and provided examples of high level investigational practices to ensure consistency and timeliness of actions impacting deviations, non-conformances and CAPAs.

Confidential, NY

Quality Analyst

Responsibilities:

• Developed and implemented strategies to successfully close 10 legacy CAPAs resulting from outstanding regulatory body observations and ISO 13485 non-conformances for a Class II Medical Device manufacturing facility. Subsequent ISO recertification resulted in no non-conformances.
• Directed CAPA remediation efforts with CAPA owners ensuring appropriate issue containment, problem statement identification, investigation, root cause identification, as well as risk assessment, corrective action and effectiveness plans implementation.
• Lead Design Control Quality Management System (QMS) gap assessment. Identified major regulatory and corporate compliance omissions impacting accurate identification of Key/Safety Characteristics, Essential Design Outputs, the Part 11 compliance of the Design History File (DHF), and change control of the Device Master Record (DMR) as well as other DHF applicable files.
• Developed and implemented a Design Control Enhancement Plan which
• Remediated the legacy Design Control CAPA backlogManaged site integration of the corporate Design Control QMS
• Managed the creation of a new DHF Change Control process for device revisions as well as new device developments.
• Managed the implementation of the ISO 14791 compliant corporate Risk Management SystemsFacilitated implementation of new or enhanced Issues Management tools, as well as
• Facilitated the launch of V8 product line extension.
• Participated in Change Review Board and CAPA Review Boards to ensure completion of changes and/or improvements to applicable systems.
• Provided CAPA metrics to identify key overdue CAPAs, owner actions, and rationale for delay.
• Coordinated and provided QA oversight on SDLC cross-functional teams which established processes to capture, escalate and resolve design issues as well as implemented desired site software tool enhancements. (BPM, TW8, TcU, MES, ClearQuest, DOORS®, etc.)
• Provided QA oversight and approval of product and/or process validation protocols, the resulting specification documentation, as well as associated Design Control SOPs.

Confidential

QA Supervisor

Responsibilities:

• Supervised six direct reports and three indirect reports.
• Responsible for third-shift QA oversight for Manufacturing, Raw Materials, Batch Release and Validation.
• Developed and maintained effective collaboration across all functional areas.
• Reviewed and approved all in-process testing. Performing testing as needed.
• QA lead for Supplier Quality Program. Completed program remediation, which ensured site compliance to corporate guidelines as well as site readiness for forthcoming regulatory body audit.
• Created and managed raw material specifications based on USP/FCC/EP compendia and/or supplier methods.
• Managed CAPA Program. Reduced backlog of CAPAs 90 days or more overdue from 22 to 8.
• Completed 2011 and 2012 Annual Product Review for both two Class III Medical Devices.

Confidential, Deerfield, IL

Senior Quality Engineer

Responsibilities:

• Provided QA oversight for cross-functional teams addressing supplier change management, component enhancements, and/or new product development.
• Managed Global Supplier Quality Approved Supplier List. Updated list based upon Confidential quality, risk and business unit requirements, an assessment of previous supplier audits, Supplier Corrective Action Records (SCAR), supplier surveys, and as necessary, site needs.
• Conducted gap assessment of the Global Quality Supplier Program. Reviewed supplier quality reports and audit files to identify deficiencies in supplier information, supplier audit documentation, and Supplier Change Notification record compliance.
• Formulated the 2009 Supplier Audit Schedule based upon deficiencies identified during the gap assessment, calculated risk data, and supplier approval classification.
• Performed external supplier audits to evaluate supplier compliance with existing Confidential Supplier Quality Agreements, 21 CFR Part 11, 21 CFR Part 820, and ICH Q7A.
• Led external audits of equipment and laboratory services providers, as well as bulk excipient and API suppliers.

Confidential, Glen Falls, NY

Design Assurance Quality Engineer

Responsibilities:

• CE Recertification Project Team Quality Engineering Lead for three Class III Medical Device product lines and kits.
• Completed product technical file (Design History Files, Product Specifications, Product Dossier) gap and risk assessment for three Class III Medical Device product lines.
• Performed internal and OEM Design Assurance site audits.
• Supervised eight indirect reports, which were responsible for execution of all CE Recertification testing.
• Provided all compliance testing (IQ/OQ/PQ) oversight for three Class III Medical Device product lines and applicable custom kits to ensure ISO 11070/10555/1099/1707 and FDA compliance.
• Authored DQMP and DVMP.
• Performed customer complaint analysis, use, design and performance FMEAs.
• Authored all supporting protocols and applicable reports for CE Recertification project.
• Investigation Lead for all validation and verification testing anomalies.

Confidential, San Diego, CA

Validation Specialist

Responsibilities:

• Completed aseptic line and process qualification (IQ, OQ, PQ).
• Authored Validation Master Plan for laboratory and manufacturing equipment qualifications (IQ/OQ/PQ), Master Production Records (batch record) and production SOPs.
• Completed cGMP audits of process and supporting quality systems.