Stephen Shields Email & Phone Number

Seattle, Washington, US

Develop computerized systems compliance Quality Management System for startup (policies, SOPs & templates). Audit Software as a Service suppliers.

Camarillo, California, US

Performed gap assessment to identify potential compliance issues for Software Development Quality Management System and regulatory compliance of Vertical-Wheel Technology product's computerized systems. Provided recommendations to correct findings. Continuing to provide guidance for improvements and assess improvement activities.

Taipei, TW

Performed pre-PMTA inspection audit of the Juul manufacturing line to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations to improve deficiencies.

Royston, Georgia, US

Performed audit to identify potential compliance issues for computerized systems’ quality management system, computerized systems validations, and electronic data integrity. Provided recommendations to correct findings.

Performed pre-FDA inspection audit of the Thai Kyowa manufacturing site to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations and action item list to correct findings.

Morris Plains, New Jersey, US

Performed post PAI inspection audit of the Immunomedics site to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations and action item list to correct findings. Developed and provided detailed assessment template for evaluating a computerized system’s compliance to US and EU regulations and.

Performed pre-FDA inspection audit of the SKAA manufacturing site to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations and action item list to correct findings.

Franklin Lakes, New Jersey, US

Established and managed remediation activities to resolve FDA Warning Letter findings related to computerized laboratory systems. Established system inventory list and performed compliance and data integrity gap assessments on systems. Recommended QMS, computer system, and data integrity improvements to meet US and EU regulations.

Seattle, WA, US

Performed Quality Systems and data center audits of hosting and IT infrastructure services provided by Secure-24. Recommended improvements to Secure-24 and Juno Therapeutics QMSs

Ramsey, NJ, US

Provided tools for assessing computerized system compliance and electronic data integrity. Performed assessments and determined remediation and mitigation activities for IT infrastructure, laboratory, manufacturing, and quality systems. Authored policies, standards, SOPs, and templates. Performed related training.

San Francisco, CA, US

Bend Research, Inc. Head of IT Quality AssuranceAssessing Quality Management System for computerized system compliance and data integrity. Strategize quality improvements. Creating/Revising SOPs and validation templates. Providing QA oversight for major validation projects (network re-qualification, SCADA infrastructure, Empower 3 custom field.

San Diego, CA, US

Illumina, Inc, Senior Validation ConsultantProviding consulting services for improvements in computerized system validation processes and support of the Pumice remediation project: validation planning, requirements generation, Part 11 assessments, risk assessments, test planning and test case development, test execution training, validation reports.

Dublin, Coolock, IE

Due to the ability to meet and exceed MBOs and implementing continuous improvements across the organization, staffing and accountabilities were expanded to include the corporate Quality Management System (QMS) for aseptic processing, sterilization, environmental monitoring and all validations (process, computerized systems, equipment, cleaning, filter...)..

Dublin, Coolock, IE

Accountable for corporate quality management system (QMS) for GMP computerized system compliance and validation. Established WWQA standards for computerized system compliance. Assessed, developed plans, and implemented plans for resolving significant compliance issues for new acquisitions. Key contributor for continuous improvements in auditing, CAPA.

Dublin, Coolock, IE

Developed and implemented global SOPs for computerized system compliance. Audited software vendors and Allergan manufacturing sites. Provided training and training materials for computer system validation and compliance, 21 CFR Part 11, good documentation practices, etc. Provided QA review for validations of Blue Mountain Calibration Manager/RAM, SAP apps.

South San Francisco, California, US

Wrote validation documents for the Plateau Training Management system and met all timelines. Received praise for the quality and conciseness of the documents.

Dublin 2, IE

Support computerized system validations for GCP systems. Developed Quality validation guidelines and documentation for use within IT and other associated Elan departments. Conducted internal and vendor audits. Created training materials and performed training for Computer Validation methodology and Part 11 Compliance. Managed validations of Argus Safety.

Gaithersburg, Maryland, US

Setup Corporate Computer Validation Department. Implemented validation methodology which resulted in robust systems being implemented within budget and having high level of user acceptance. Implemented risk assessment to establish appropriate level of validation. Managed validation budgets. Managed validation staff and consultants worldwide. Managed.

Dublin, OH, US

Designed and implemented one of the largest TotalChrom Client/Server Data Acquisition systems in the world. Managed validation of Labware LIMS system, Calibration Manager, various laboratory instruments. Collaborated with corporate QA staff to design global compliance program.

Cary, NC, US

Performed code fixes for SAS Multi-Dimensional Database software using C.

Provided on-site technical support at North Carolina Wildlife Department. The EDS system was used for hunting and fishing licenses and boat tags.

Certification/Ms Graduate Studies, Computer Science

Ms Graduate Studies, Chemistry

Bs, Chemistry