Jacqueline A.

Senior Quality Systems Specialist @ LifeScan

About

With over two decades of progressive experience within respected organizations, I have proved time and again my ability to leverage a holistic vision of internal capabilities, industry best practices, and regulations to devise and deliver effective strategies supporting long-term goals. Recognized as a flexible and cooperative team player, I take pride in building fruitful partnerships with a wide range of stakeholders, supporting the seamless execution of large-scale cross-functional projects, delivering targeted training yielding immediate results, and contributing to cultures of collaboration, innovation, and continuous improvement. Highlights of my career include: ✶ Served as a core member of a team that implemented a new eQMS for training, Corrective and Preventive Actions (CAPAs), nonconformities (NCs) and Management of Change (MOC). Ensured all relevant data was set up in a format to be successfully transferred over from the previous system and training was prepared and delivered to the business for a smooth transition. ✶ Played an instrumental role in ensuring that the global company-wide goal of ≥97% training compliance was consistently achieved by generating insightful metrics reports, following up regularly with key stakeholders, and providing coaching and education as required. ✶ Monitored training compliance via metrics reports and followed up with employees and managers to achieve ≥ 97% timeliness. Here is a snapshot of my key skills and expertise: ✶ Documentation Management ✶ Standard Operating Procedures (SOPs) ✶ Training and Development ✶ Regulatory Requirements Compliance ✶ Documentation System Maintenance ✶ Project Management ✶ Training Effectiveness Assessment ✶ Audit Documentation Review and Update ✶ Cross-Functional Collaboration ✶ Change Management Oversight ✶ Adherence to Timelines, Goals, and Objectives ✶ Complex Problem Solving

Country

Canada

City

Vancouver

Industry

Medical Device

Skill

Corrective and Preventive Action (CAPA), Supplier Quality Management, Supplier Quality, Quality System Compliance, Jira Service Desk, Document Management, Key Performance Indicators, Quality Assurance, Problem Solving, Training, Issue Management, CAPAs, Learning Management Systems, Learning Management, Business Requirements, Articulate Storyline, Group Presentations, Technical Writers, Interpersonal Skills, Technical Documentation

Experience

Senior Quality Systems Specialist

LifeScan

2018-10 - 2024-3 · 5 yrs 6 mos

Burnaby, BC

Took on all duties of the Quality Systems Specialist role at Johnson & Johnson described below, while also serving as a Quality System Administrator. Partnered with the global quality and technical support teams to resolve complex issues and fostered a positive, supportive work environment.  Played an instrumental role in ensuring that the global company-wide goal of ≥97% training compliance was consistently achieved by generating insightful metrics reports, following up regularly with key stakeholders, and providing coaching and education as required.  Conducted investigations, escalated quality events, and acted as ISO 13485 Lead Auditor for internal, distributor, and supplier audits.  Attended quarterly management review meetings, preparing engaging slides and presenting key data to inform decision-making.  Participated in late-stage customization activities and supported quality activities for inventory management within the ERP system.  Served as a core member of the team that implemented a new eQMS for training, Corrective and Preventive Actions (CAPAs), nonconformities (NCs) and Management of Change (MOC). Ensured all relevant data was set up in a format to be successfully transferred over from the previous system and training was prepared and delivered to the business for a smooth transition.

Quality Systems Specialist

Johnson & Johnson

2008-9 - 2018-9 · 10 yrs 1 mo

Burnaby, British Columbia, Canada

Supported and maintained the customized LMS platform, delivered quality systems training, and supported end users by troubleshooting issues.  Created, revised and released controlled documents including company policies, SOPs, and general guidance documents.  Designed and developed e-learning content and delivered training to further enhance employee engagement.  Generated Medical Device Problem Reports within the complaint management system and submitted to Health Canada within deadlines.  Provided front-end support for internal and external audits, including the deliverance of audit-readiness training.  Monitored training compliance via metrics reports and followed up with employees and managers to achieve ≥ 97% timeliness.

Customer Service Specialist

Johnson & Johnson

1996-3 - 2008-8 · 12 yrs 6 mos

Burnaby, BC

Co-operative Education Coordinator

Simon Fraser University

1995-2 - 1996-3 · 1 yr 2 mos

Burnaby, BC

Recruited employers for co-operative education employment of university students. Performed site visits during co-op work terms and reviewed work reports submitted by students at the end of their work terms. Also presented information on the co-op education program to high school students in the lower mainland.