John Rasinske

About John Rasinske

Extensive IT management, GxP compliance, and software quality assurance (SQA) for custom developed and highly configured commercial off-the-shelf (COTS) software across multiple architectures. Deep experience with the development and rollout of software development lifecycles (SLC), application lifecycle management (ALM) tools, and software test automation. Experience with leading and implementing process improvement initiatives to reduce costs, lower cycle times, and improve efficiency. A proven track record for developing, staffing, training, and managing high-performing IT resources that meet both quality and project schedule expectations.Specialties: Current Good Manufacturing Practices (cGMPs), including 21 CFR Parts 210 and 211 & Federal Regulations on Electronic Records; Electronic Signatures (21 CFR Part 11); Capability Maturity (CMM - SEI); Rapid Application Development (RAD); Software Project Estimation; Requirements Management, Software Configuration Management (SCM); Risk Management; and Object Oriented Analysis & Design (OO).

Experience

1. Sr IT Manager, Business Systems Analysis

   Labcorp

   Aug 2009 — Present · Durham, NC, US

   As the leader responsible for software quality assurance (SQA), software test automation, validation and audit readiness, I ensured the success of in-house, custom-developed laboratory information management (LIMS) and supporting systems for drug development clinical laboratories worldwide. With a team of full-time and contract employees, I oversaw training, development, and annual performance reviews while adhering to strict GMP and 21 CFR Part 11 (FDA) regulations.I spearheaded a significant change from a traditional waterfall testing approach to an agile/automated testing paradigm, revolutionizing our SQA organization. Through this transformation, we optimized our testing processes, reduced errors, and sped up our testing cycles.To streamline our validation artifacts, I implemented HP ALM with 21 CFR Part 11 compliant eSignature review and approval across our IT organization, including Development, Release Management, Business Analysis, and SQA. I wrote all standard operating procedures (SOPs) and work instructions (WIs) to ensure compliance with regulatory requirements.To support our front-line personnel, I designed, developed, and produced short-form video training content that augmented our SOPs and WIs, making it easier for our team to master the ALM toolset. Through my leadership, we achieved outstanding results and set a high bar for excellence in software validation.

Education

• University of Wisconsin-Whitewater

  Bachelor of Science, English

Skills

• Systems Analysis
• User Acceptance Testing
• Software Documentation
• Sdlc
• Business Analysis
• Analysis
• Quality System
• Test Planning
• Integration
• Project Portfolio Management
• Vendor Management
• IT Management
• 21 Cfr Part 11
• Visio
• Quality Center
• Process Improvement
• Software Development Life Cycle (Sdlc)
• Management
• Team Building
• Quality Assurance
• System Testing
• Requirements Gathering
• Software Project Management
• Leadership
• Team Leadership
• Requirements Analysis
• Software Quality Assurance
• Sharepoint
• Training
• Testing
• Project Management
• Test Automation
• Computer System Validation
• Db2