SQA, Validation, Pharma, Device, Quality and Business Process Engineer

PROFESSIONAL EXPERIENCE

Company Confidential, Medical Device Industry, MA

Senior Quality Assurance Engineer

From: 06/2008 - To: Present

•Responsible for managing and remediating eighty mobility apps to comply with issues identified in a corporate CAPA.

•Serve as Business Analyst facilitating the development of requirements specifications, business process flows, use cases, design standards, trace matrices, work instructions, test cases and support documentation.

•Serve as Quality PM working in coordination with the PMO office, Project Managers and business owners to develop project planning and scheduling documents, manage project resources and monitor timelines.

•Provide mentoring and professional guidance to project team members and subordinates on topics such as SDLC methodologies, regulatory compliance, interpreting and implementing corporate policies and change management.

•Perform internal process audits and vendor assessments ensuring adequate processes, security, training, disaster recovery, development and design practices are established, documented and implemented.

•Successfully streamlined an “Off The Shelf” validation methodology that resulted in a sixty percent reduction in the time required to implement as well as a twenty five percent reduction in resource requirements and overall project costs.

•Provide support and training to Business Owners and Project Managers on appropriate “least burdensome” validation approaches to ensure compliance with internal policies and external regulations.

•Provide technical and compliance input for various corporate development lifecycle methodologies, procedural, training and process documentation deliverables.

•Assign and manage Quality project resources to ensure adequate coverage and competencies required to provide adequate project coverage.

•Managed the quality deliverables for the validation of an ethylene oxide sterilization system used in medical devices.

Logically Speaking, LLC, Campton, NH

Manager I – Contract Quality Assurance

From: 03/2006 - To: 06/2008

•Responsible for identifying and managing client expectations through detailed project planning, resource management and contract negotiations.

•Developed, deployed and managed product quality assurance methodologies addressing all phases of a products lifecycle.

•Managed a team of full time and contract SME’s ensuring resource availability as required per business need.

•Tracked resource budgeting and time estimations ensuring compliance with contractual obligations, client expectations and corporate objectives.

•Actively participated in process improvement initiatives assisting with the piloting and training of enterprise software engineering and quality control methodologies.

•Served as escalation point for all contract quality related issues, negotiated resolutions with clients and facilitated the escalation of critical issues to senior management.

•Developed and presented training sessions on topics including regulatory compliance, validation, testing, good documentation practices, requirements development, risk analysis and remediation.

•Developed a validation methodology for computerized systems within regulated environments that reduced time to production by fifteen percent.

•Overhauled and existing change management system reducing the number of required review cycles by one third.

•Streamlined a system maintenance classification process eliminating the need for routine maintenance tasks to follow the intensive validation process.

•Managed employee performance and incentive program providing feedback, reviews, ratings and goal setting for upcoming year.

•Developed equipment and software validation packages made available to clients to perform their own internal validation activities which resulted in an additional corporate revenue stream.

Logically Speaking, LLC, Campton, NH

Principal Quality Systems Engineer

From: 08/2002 - To: 03/2006

•Audited business units and service providers to ensure proper development and management practices and to identify any deficiencies which may have an adverse affect on the business or pose a risk to its clients.

•Analyzed business impact as it relates to the implementation of software products designed for the creation, tracking and submission of clinical trial and investigational drug application data.

•Managed resources and activities associated with hardware and software implementation projects.

•Analyzed system designs, user and functional requirements to ensure that proposed solutions meet or exceed predetermined operational and process related benchmarks.

•Performed CAPA and Risk Based Analyses of quality systems, processes and corporate procedures.

•Oversaw the implementation of remediation tasks and deliverables developed as result of findings noted during CAPA and Risk Based analyses.

•Managed regression and pre-release testing of custom and COTS software packages, web based systems, client/server applications and Software-As-A-Service solutions.

•Analyzed and developed corporate business procedures, resource management and process workflows.

•Provided professional guidance and technical support for issues relating to FDA 21 CFR’s 11, 101, 110, 201, 210, 211, 58, 801, 820 and 861 as well as cGxP’s, ISO and GAMP guidelines.

•Performed the role of Business Analyst to develop user requirements, functional specifications, design documentation, testing protocols, user manuals and service field work orders.

•Developed business critical documentation such as but not limited to SOP’s, SWP’s, project plans, design and functional requirements, UAT’s, FAT’s, user manuals and QA procedures.

Roche Diagnostics, Inc., Belleville, NJ (Pharma)

Manufacturing Support Engineer

From: 05/1995 – To: 06/1998

Hoffmann – LaRoche, Inc., Nutley, NJ (Pharma)

Information Technology Analyst

From: 06/1998 - To: 09/2000

CTC Comms., Waltham, MA (Telecomm)

Sr. Network Engineer

From: 09/2000 - To: 06/2002

PROFESSIONAL ACCOMPLISHMENTS

•Streamlined an existing COTS SDLC methodology resulting in a 40% reduction of time to implement and reduced capital expenditure by 18% while maintaining existing production support and validated state.

•Developed an intake process for mobile standalone applications resulting in a reduction of time to deployment as well as increased efficiency of asset and application management.

•Developed and implemented a Risk Assessment evaluation process for mobile computing systems to ensure compliance with updated rules/regulations for the mobile computing space within regulated environments.

•Presented with a corporate SPOT recognition award for work performed on the validation and remediation of Quality mobility applications.

PROFESSIONAL SKILLS

•In-depth knowledge of cGxP, GAMP, ISO and FDA 21/810/820/45/210/211 CFRs

•Process and business documentation development based on SDLC and ITIL framework

•Validation and qualification of computerized systems, software applications and business processes

•Black Box “Behavioral” and White Box “Structural” testing experience

•Technical training and development

•Automated testing experience

•Project planning and management

•Excellent conceptualization and problem solving skills

•Risk Based validation assessment and remediation

•Excellent written and communication skills

•Information and data management

•CAPA assessment and remediation

•Business analysis and development

•HIPAA and HITECH Implementation and Enforcement

•Agile/Scrum/Waterfall/RAD/ V-Model/ Spiral SDLC’s

•Technical writing

PROFESSIONAL EDUCATION & CERTIFICATION

•Bergen Community College

A.S., Business Management (GPA: 4.0)

•NavisLearning, Inc.

Professional Technical Writing

•NavisLearning, Inc.

Business Writing

•American Management Assoc.

Project Management Professional

•ASQ

CSQE Certification

•NavisLearning, Inc.

Problem Solving for Professionals

•Element K, Inc.

Microsoft Sharepoint 2010 Server

•Minitab, Inc.

Hands on Statistics with Minitab

•Corporate Training

ORM Business Data Modeling

•Franklin Covey, Inc.

Seven Habits of Highly Effective People

SOFTWARE APPLICATIONS

•Adobe Acrobat, Framemaker, Photoshop

•Microsoft Office Suite/Visio/Project/Share Point

•Windows XP/2000/2003 Ent. Server

•EMC Documentum

•Windchill PDM

•VM Ware Workstation and Server

•Info Router

•Apple OSX and IOS

•Linux

•Python programming

•IBM ClearCase and ClearQuest

•Minitab 16

TECHNOLOGY SYSTEMS

•Programmable Logic Controllers (PLC’s)

•Radio Frequency Identification (RFID)

•Document Imaging and Distribution

•Robotic material management and distribution

•Calibration Management

•Electronic Submissions

•EDI Transactions and Translation

•SCADA and microprocessor controlled manufacturing

PERSONAL ACCOMPLISHMENTS

•Honorably served in the United States Navy

•Member: Association of Teachers of Technical Writing

•Inductee: National Deans List

•Member: Phi Theta Kappa Honor Society

•Member: American Society of Quality (ASQ)

•Member: National Association of Independent and Professional Consultants

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