April Fry

Apollo Beach, FL · 352-***-**** · adg61s@r.postjobfree.com

Accomplished quality and labeling compliance leader with 12+ years of medical device, cGMP experience and 3 years of International Pharma labeling compliance. In-depth experience of labeling system management, process and procedure optimization, design and development process controls with Six Sigma applied. Working knowledge of IT system validation including OQ, IQ and PQ documentation writing.

Strong supervisor and project management skills from years of experience developing, driving and maintaining compliant end-to-end labeling procedures and systems for multiple medical device manufacturers. Direct industry application experience coupled with knowledge of the regulatory and quality standards. Experienced in all aspects of product lifecycle management, risk management and review – specializing in new product development and process compliance. Extensive knowledge and background with all aspects of manufacturing, IT system interaction, process transfer from paper to electronic and the importance of understanding process flow impact. Organized, self-motivated and take charge drive that embraces improvement, teamwork and applying lessons learned globally.

Key Skills & Core Competencies

Product/Brand Management

End-2-End process mapping

Design and Development Process Control

cGMP, FDA, ISO & International Regulations

FMEA, SOP and Product Requirements

Regulatory Knowledge &

Audit Experience (supplier compliance, internal, FDA)

Product Lifecycle Management

Complaint Review and Risk Management

Team Leadership & Development

Professional Experience

Sr. Lead, International Labeling Operations

Bristol-Myers Squibb - Tampa, FL September 2016 - Present

Manager, coordinator, support and assist with labeling documents (From submission to production release)

Help determine current and future system changes, improved communications, and simplification including best practices for all supported Countries.

Hire, train, mentor and assist with development of the team of Labeling Specialists for all products and regions supported.

Advice, create labeling documents and assist Country labeling submissions using approved reference CCDS or reference market approved content such as USPI or SmPC.

QC Consultant

Thermi - Irving, TX February 2016 - September 2016

(QC Consultant – QMS review, Audit readiness and process improvements for medical device labeling)

Work with all departments and all levels of management to help determine process gaps and audit risk levels for entire QMS to ISO 13485, FDA 21 CRF and BS EN 60601 labeling.

Perform internal review and audit of procedures and leased quality system.

Help determine required system changes for compliance, or general process improvements then advise on risk levels.

Run UDI compliance and system setup project, including restructuring labeling process flow and file transfer between contract manufacturers.

Product Manager – Development, Design & Labeling

Genesis PURE - Frisco, TX June 2014- January 2016

Led collaboration with R&D, Regulatory Affairs, Supply Chain and other key stakeholders in the evaluation, development and launch of new products including all labeling during Product life cycle.

Perform quality testing and R&D formulation taste testing, advised on changes to meet market needs.

Enforced product quality and full product life cycle management.

Designed and executed product promotions for new and revised product launches

Developed product specification documents, product analysis sheets for marketing promotional use

Performed consumer and competitor research

Reviewed and edited materials for product launches or seasonal promotions, including ask the expert posts or responses in regards to NSF/SFP labeling content (Nutritional or supplemental facts panel)

Global Labeling Supervisor

St. Jude Medical - Plano, TX November 2010- June 2014

Manage labeling development, printing, template data transfer and manufacturing process flow.

Supervise, train and support both direct reports and entire labeling development team on both Quality and Regulatory compliance needs for both domestic and international standards.

Perform process reviews, compliance verifications and support internal and external audits as SME

Create, manage and maintain labeling process, labeling life cycle management.

Work with all development teams as expert on label compliance, process impact and data system capabilities.

Developed, maintained and performed labeling verification audits and regulatory confirmation reports.

Review system wide impact, design and development of implementation plan and training to UDI requirements.

Sr. Regulatory Labeling Specialist

RTI Surgical - Alachua, FL May 2007 – November 2010

Support and manage labeling system, design, and compliance of manufacturing process.

Perform label programming and confirm compliance for both medical device and HCT/P regulations.

Participated in all development teams as a Quality, Regulatory & Labeling compliance SME, while leveraging QC and manufacturing background for risk assessments and FMEA (Failure Mode and Effects Analysis) development.

Provided guidance on system capabilities, risk assessment, compliance, cost analysis and process risk.

Reviewed projects and labeling changes for domestic and international compliance or impact

Review and respond to UDI requirements, perform impact assessment.

Reviewed and wrote the impact and implementation plan for Biologics identification and classification requirements (HCT-P equivalent to device UDI).

Quality Coordinator/Packaging Specialist/BioCleanse Operator November 2002 – May 2007

Inspect, package, maintain sterility of environment and implants during processing

Process audit, first article and final inspection, risk and compliance analysis

Train and observe new employees on all job functions and procedures

CAPA assessments, 5-Pillars (Six Sigma designed program)

Process, measure, package and inspect products for conformance to specifications as quality review

Complaints & Returns Inspection in conjunction with a First-Party Audit of Alabama Tissue Center.

Forensic Assistant

Coconino County Medical Examiner’s Office - Flagstaff, AZ January 2002 – November 2002

Assist investigations, evidence gathering, specimen collection including autopsy prep and procedure

Maintain chain of evidence, clean examination room to keep aseptic environment

Research and assist law enforcement with identification of john doe/jane doe cases

OTHER SKILLS &

KNOWLEDGE

Systems and Programs (Word, Excel, Access, PowerPoint, Project, ByDesign, SAP, CATSWeb, WorkFront/AtTask)

Labeling Software/Coding exposures: Innovatum, Loftware, BarTender, ZPL-code

FDA (CFR Title 21 Part 801, 820, 821,1270 & 1271 and cGMPs

ISO 13485, ISO 14971, BS EN 45502, BS EN 1041, BS EN 14708 & BS EN 60601-1 & -11

Health Canada: Medical Device & Human Cells, Tissue and Organs

Sterile technique and gowning procedures for controlled environments: Class 10-5

Compliance auditing and supplier qualification and quality review

Design & Development process and change control procedures

EDUCATION

& TRAINING

Bachelor of Chemistry – (Graduated 2001)

Northern Arizona University, Flagstaff, AZ

Emphasis in Preforensics and Criminalistics

Associate in Pre-science – (Graduated 1998)

Coconino County Community College, Flagstaff, AZ

CERTIFICATIONS

Certified Quality Auditor #32392 (American Society for Quality, 2005-2010)

Tissue Specialist CTBS #905084 (American Association of Tissue Banks, 2005-2010)

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