Summary

Work History

Education

Skills

Work Availability

Certification

Software

Affiliation

Training

Angela Pontello

North Attleboro,MA

Summary

I am a quality and compliance focused professional with proven expertise in technical support, documentation, and regulatory compliance. My expertise lies in devising and implementing Quality Assurance standards for Information Technology and software development. I am a strategic leader; excel at collaboration with Technology Solutions and virtual teams across global location to formulate strategic directions for product and software support.

Throughout my career, I have utilized my skills to develop comprehensive processes, procedures and policies to ensure compliance with industry standards and regulations.

Work History

Director of Quality

Metrum Research Group

Tariffville, CT

07.2019 - 03.2023

Designed a comprehensive Quality Management System.
Creation, oversight and implementation of new SOPs and Policies; expanding QMS to support CSV and SDLC.
Process improvement for CAPA, deviation, change management and risk analysis and mitigation.
Process improvement and implementation of LMS; regulatory and department specific training.
Review and approval of all regulator documentation; including but not limited to SOP, Policies, Forms, validation documentation, OJT material.
Implementation and participation in establishing GDPR regulation/legislation policies and procedures.
Created and implemented comprehensive Quality Management Plan, focus on Part 11, Annex 11, GAMP and ISO standards.
Establish and maintain Quality specific metrics.
Establish and manage Sponsor Audit program and Vendor Audit management program.

Quality Services and Improvement

Takeda Pharmaceuticals

Cambridge, MA

10.2015 - 07.2019

Initiated and maintained a timeline for Clinical GMP facility startup.
Managed communication workflows with stakeholders to identify required resources including time, budget, equipment.
Operational excellence approaches, lean principles, and various tools to spearhead and direct projects within defined timelines and budgets.
Ensure and monitored progress of site compliance with key members of cross-functional teams.
Collaborate with key members of cross-functional teams to ensure site compliance.

Associate Director

PAREXEL

Lowell, MA

08.2012 - 05.2014

Strategic and day to day Quality Management for software/products, including development and maintenance of Standard Operating Procedures, and responsibility for their dissemination and use across various engineering areas
Support internal maintenance of departmental software development life cycle documentation
Engage engineering areas in the resolution of Quality and Process issues
Facilitate meetings as required
Planning, conduct and follow up of internal Quality Assurance audits and Sponsor/Agency audits in a multi-disciplinary software/product environment
As well as follow up and closure of actions
Support and participation in Bid Defenses, Due Diligences and Sponsor Partnerships
Definition and development of Software Development TQM metrics and objectives
Identification of opportunities for process improvement and assist engineering teams in the implementation of appropriate improvement measures
Liaison with other Perceptive and PAREXEL quality personnel, participation in the rollout of corporate PAREXEL and Perceptive wide initiatives
Plan and conduct process and regulatory training as required.

TQM Quality Manager

PAREXEL

Lowell, MA

05.2011 - 08.2012

Provide leadership and direction to (Sr and I/II) Specialists
Mentor and train (Sr and I/II) Specialists.
Supervise quality management projects including oversight of team members as assigned.
Promote a positive, results orientated work environment, build partnerships and model teamwork, and communicate to others in an open, balanced and objective manner.
Deliver best value and high quality service for the benefit of PAREXEL and ensure compliance with PAREXEL Quality standards, Controlled Documents and appropriate regulations.
Lead the testing of large functional, or cross-functional, systems and tools in line with IT, PAREXEL Operations and PAREXEL Quality Management strategies
Participate in large scale or complex IT infrastructure& systems implementation teams and or consult teams during large scale software development projects.

Senior Validation Specialist

PAREXEL

Lowell, MA

04.2009 - 01.2011

Lead the implementation of functional or small cross functional, systems and tools in line with operations and Quality Management strategies
Participate in large scale or complex systems implementation teams and support pilot study activities
Support development and implementation of project plan, as required, for assigned projects
Document user requirements and provide and/or provide support to CSV leads on large scale projects
Act as CSV lead on assigned projects and/or provide support to CSV leads on scale projects
Act as Designated Responsible Individual (DRI) for assigned systems
Prepare, review and maintain relevant Controlled Documents
Provide Technical training, support and advice to operational groups on the use of systems including adherence to applicable processes
Perform hand-off tasks to relevant groups such as Process and Training, as required
Keep abreast of regulatory requirements and represent PAREXEL systems at regulatory inspections, audits and/or client audits
Initiate escalation of significant quality events to Management as required
Train and mentor less experienced Technical Specialists
Perform all tasks as reasonably requested.

QA Validation - Contractor

Abbott Bioresearch Center

Worcester, MA

08.2006 - 02.2008

Responsible for managing documentation and performing validation functions to support new and existing programs in all Abbott divisions (e.g
IS/IT, Instruments and Controls, Quality Control and Operations Engineering)
Duties include reviewing pre and post execution of validation protocols (IQ, OQ, PQ), technical reports, SOPs, SAD, SFS, DDS, and Traceability Matrix, engineering documents/diagrams/CAD drawings
Approving and reviewing Test Method transfers/Test Methods/Protocols and other validation documents in regards to Quality Control
Review and approval of validation of Quality Control instrumentation
Primary responsibility for IS/IT; authorizing, approving purchasing and updating corporate 21 CFR Part 11 Database in regards to compliance with 21 CFR Part 11 and predicate rules
Inventory and Security Gap Assessments and remediation in regards to corporate 21 CFR Part 11 tracking and inventory tool
Review protocols from approved vendors, and review of documentation (protocols/code) after execution
Review and verification of Validation Database Audit trails for QA Manufacturing Databases and QA Validation Database
Review and edit drafted SOP forms and instructions
Authored and approved Validation Investigation reports
Train personnel in validation (21CFRpart11) requirements and practices as well as validation documentation practices
(Including one-on-one training with personal if requested)
Update Training Presentations in regards to 21 CFR Part 11
Assist manager in daily operations
Performed Internal Audits of IT/IS procedures, policies, validation packages and SOPs for Compliance department
Participated in FDA audits.

21 CFR Part 11/IT Analyst - Contractor

Avant Immunutherapeutics, Inc.

Fall River, MA

08.2004 - 01.2006

Managed and hired vendors/contractors for Network, Systems, Software and Phone wiring and hardware installation
Conducted computer application system assessments to indicate areas of improvement or problems; this included manufacturing, QA and network software and its operations
GAP Analysis and Risk Assessment drafting, executing and documenting
Creations and development of computer master validation plan, network, manufacturing, construction CAD drawings and implementation
Development and implementation of 21CFRpart 11 documentation processes/controls and in house training
Validation of CPU’s, PLC’s and Off the Shelf (COTS) Software
Worked with QA and Agilent software and computer hardware to ensure compliance and validation was met
Development of corporate computer ethic policies/documentation as well as the documentation and execution of Backup/Recovery Contingency Planning
Drafted and ensured compliance of URS, IQ, OQ, PQ and FAT documents for laboratory computer systems
Worked with Finance to ensure proper compliance and documentation for Sarbanes-Oxley
Analyzed, defined, set up and documented computer functionality; this included manufacturing, QA and network software and its operations.

IT Documentation/Compliance/DBA

Chemic Laboratories

Canton, MA

03.2002 - 03.2004

Project leader of 21CFR11 documentation and implementation of processes/controls for IT
Presentation and training session on the guidelines of 21CFR Part 11
Development of documentation and implementation of GAP analysis and Risk Assessment and development of Master Validation/Computer Validation Plan
Development of documentation and maintaining URS, IQ, OQ, PQ for laboratory computers
Worked with chemists to setup and maintenance for HPLC runs, using Chemstation
Calibration of pipette’s and sample set ups for various equipment testing; HPLC, GC, UV-Vis, and FTIR
Maintained/developed company database
DEA and Radiation trained
Drafted and updated standard operating procedures
Maintained documentation for monitoring laboratory and desktop/office computer systems, as well as equipment/assets inventory control
IT/Network and desktop/printers including network and phone wiring, hardware installation of cat5e cable, RJ45, data/tel port connectivity testing and connecting.

QA Raw Materials Analyst

Lonza Biologics

Portsmouth, NH

03.2000 - 08.2002

Designed and maintained central documentation training management database system (also for other departments i.e
Materials Management, Documentation and Compliance)
Implementation/drafting of DCRs and Change Controls for Raw Materials Group
Developed effective electronic workflow of data generated using Excel and Access
Updating/auditing SAP/3 database
Updating/drafting standard operating procedures, as well as the generation and updating of material specifications
Audited, Filed and processed raw materials groups completed test forms and results
CGMP, ISO 9000 and GLP trained
Member of the Materials Review Board.

Education

Masters - Information Technology

American InterContinental University

Hoffman Estates, IL

01.2011

Bachelors - Information Technology/Computer Systems

American InterContinental University

Hoffman Estates, IL

09-2010

Skills

Compliance (GxP, FDA, EU, GDPR etc)
eQMS; CAPA, Deviations and Change Management
SDLC/CSV (automated/manual testing)
21 CFR Part 11, Annex 11 (ERES)
Risk Analysis and Mitigation Planning
Root Cause Analysis
Agile Methodology

Cross-functional Team Development
Privacy and Data Integrity
SOP and Process Implementation
Creating and Execution Training Programs
Knowledge and performance of Regulatory and Sponsor Auditing Systems
SaaS, PaaS and IaaS structure knowledge

Work Availability

monday

tuesday

wednesday

thursday

friday

saturday

sunday

morning

afternoon

evening

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Certification

Certified Scrum Product Ownver (CSPO), Scrum Alliance
Certified Scrum Master (CSM), Scrum Alliance
LSS, Pysdek Institute
Advanced Agile Business Solutions, Villanova University
Essential Principles of Agile Management, Villanova University

Software

Java

Selenium

Maven

TestNG

API

Cucumber

SQL

NetBeans

Eclipse

Jira

Replit

Git

Affiliation

Associate Member, ASQ, 2008-Present
Member, New England Regional Chapter Society for Quality Assurance, 2001 to Present
Member, PMI, 2010 to Present
Member, ISPE, 2010 to Present
Member, ACM, 2010 to Present
Member, IEEE, 2010 to Present

Training

AI in Quality Management - Quality Digest, 2024
Lean Six Sigma Certificate – Yellow Belt, 2009
Electronic Regulatory Submissions to FDA –NERCSQA, Sturbridge, MA, 2005 to 2005
E-Signature (e-sig) Systems for Control Documents: Using Part 11 to Benefit Your SOP System, NERCSQA, Sturbridge, MA, 2005 to 2005
Archiving Design and General Archiving Issues, NERCSQA, Sturbridge, MA, 2005 to 2005
Proficy iHistorian Development, GE Fanuc Automation, Plymouth, MA, 2005 to 2005
Current FDA Activities around Validation/Data Security, NERCSQA, East Hartford, CT, 2003 to 2003
Current FDA Computer Validation Activities Including the New Part 11 Document, NERCSQA, Hartford, CT, 2003 to 2003
Data Security Including Network Security, Backups, Archiving and Contingency Planning, NERCSQA, East Hartford, CT, 2003 to 2003
Windows Sever 2000, New Horizons, Burlington, MA, 2002 to 2002
FDA Training on 21CFR part 11, NERCSQA, 2002 to 2002
Bioethics in Corporate Context, NERCSQA, Waltham, MA, 2002 to 2002
Ethics, Training, Fraud Prevention and Detection, NERCSQA, Waltham, MA, 2002 to 2002
Computer Applications, UNH, Durham, NH, 1999 to 1999
Management Workshop, ML Hanney, Inc, Portsmouth, NH, 1999 to 1999

Angela Pontello

Summary

Work History

Director of Quality

Quality Services and Improvement

Associate Director

TQM Quality Manager

Senior Validation Specialist

QA Validation - Contractor

21 CFR Part 11/IT Analyst - Contractor

IT Documentation/Compliance/DBA

QA Raw Materials Analyst

Education

Masters - Information Technology

Bachelors - Information Technology/Computer Systems

Skills

Work Availability

Certification

Software

Affiliation

Training

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