Steven Danglay is a well-rounded individual with experience in Quality Assurance (QA) and Quality Control (QC) in Canadian and U.S. pharmaceutical and biotech companies. His cheerful attitude, expertise, and attention to detail make him a valued project leader and/or team member. His experience, training, and knowledge make him a valuable addition to the Q&C team.

Large Compliance Project Consulting

• Planned/monitored release of biotechnology products
• Audited QC testing and QA systems
• Coordinated stability programs

Quality Assurance/Quality Control (QC)

• Successfully implemented tools and standard operating procedures (SOPs) to institute metrics and deviations tracking for monitoring laboratory testing performance and promoting cycle-time reductions
• Performed as lead auditor of QC laboratories and QA systems on cGMP compliance and testing performance, authored audit reports, hosted external vendor audits
• Investigated root causes for cGMP deficiencies and testing delays to improve efficiency; created process maps to identify gaps and provide solutions (develop SOPs, evaluate systems), and neutralize gaps in documentation, sampling, and testing.
• Monitored manufacturing, validation, and stability testing schedules; developed tools to collect metrics to audit test cycle times, batch release, and assay failures
• Monitored sample distribution and testing by maintaining audit trail systems (e.g., LIMS, tracking calendars)
• Prepared Certificates of Analysis for release of products.
• Audited local site practices at biotech company and vaccine manufacturer
• Authored policies and procedures to implement improvements and harmonization opportunities with global/corporate groups
• Led a cross-functional task force team which developed an approach for addressing the stability of multi-component vaccine products and substances/ intermediates; remedied deficiencies, developed complex stability programs
• Designed and coordinated stability surveillance studies for licensed vaccines with industrial operations (testing laboratories, regulatory affairs, manufacturing)
• Ensured stability programs satisfied company quality and cost needs, cGMP, and regulatory requirements for licensure, post-licensure changes, and development
• Provided training on new Quality Operations systems and procedural enhancements
• Ensured departmental productivity by training staff on new improvements to continuously succeed in regulatory inspections
• Developed electronic documentation portal on corporate Intranet for QA/QC documents (Certificates of Analysis, NWA Trending charts). Provided global, corporate-wide access to Release and QA documentation

• BSc Honours, Life Science (Microbiology, Immunology, Biochemistry, Molecular Biology), Queen’s University, Kingston, Ontario

• Auditing Skills
• Drug Product Stability and Shelf-Life, Center for Professional Advancement
• GMP for Importers/Distributors, Q&C
• GMP Overview
• GMP Training, Biogen Idec
• Graduate Certificate, Administration and Management, Harvard University Extension School, Cambridge, Massachusetts:
• Communication in Business, Harvard
• Information Technology, Harvard
• Organizational Behavior, Harvard
• Project Management, Harvard University Extension School, Cambridge, Massachusetts
• Industrial Drug Legislation, Seneca College
• Labware LIMS, Biogen Idec & Labware LIMS Solutions, Research Triangle Park, NC
• LIMS Reporter (Infomaker) for Nautilus, Thermo Scientific, MA
• Technical Writing Course, Q&C