Clarissa Lynn Robertson
Boston,MA
Quality is not an act, it is a habit.
Aristotle
Summary
Senior Quality Assurance Leader with 15+ years of GMP experience across Quality systems, laboratory operations, Contamination Control, Facility and Engineering oversight, and Change Management. Proven expertise in leading root cause analysis, deviations, CAPA, OOS/OOT investigations, and Change Control assessments and approvals. Known for aligning quality initiatives with business objectives while advancing a culture of compliance, operational excellence, and stakeholder trust. Recognized SME in Change Management with a strong record of leading cross-functional initiatives that drive efficiency, improve audit readiness, and enhance product delivery in fast-paced biotech environments.
Overview
16
16
years of professional experience
Work History
GMP Operational Quality Senior Specialist
Vertex Pharmaceuticals
06.2021 - Current
- Provide end-to-end QA oversight across RSL, CQC, Kilo, EM, and UM laboratories, as well as Facilities, Engineering, Validation, and Manufacturing operations, ensuring alignment, operational consistency, risk-based decision making, and end-to-end quality oversight for Change Controls, deviations, CAPAs, and effectiveness checks to ensure compliance with regulatory and internal standards
- Led development and implementation of key GMP projects, including bulk nitrogen identity testing program, risk assessment and approval of Utilities sampling site and frequency reduction, and Kilo laboratory facility modification, equipment onboarding, and Predefined Change Control processes
- Partnered with Facilities, Reliability, and Metrology teams to optimize return-to-service timelines and streamline CMMS workflows, targeted to save 90+ productive hours in Nuvolo annually
- Active participant in the monthly VCGT-VMC Quality Assurance Engineering forums, discussing ongoing projects and continuous improvements, assessing events, strengthening alignment and collaboration between the groups
- Created and delivered practical, targeted training, job aids, and procedural documentation for CMMS, GDocP, contamination control, and change management practices, strengthening collaboration between QA and stakeholders
- Supported site-wide audit readiness initiatives and contributed to data-driven KPI tracking and reporting
- Reduced Change Control QA impact assessment rejections by 43% and shortened review timelines by 50%, significantly improving efficiency
- Led Continuous Improvement Gallery Walk presentation on mature Change Management processes to VP stakeholders and cross-enterprise Vertexians
- Drove operational enhancements projected to save over 90 productive hours annually through CMMS system and workflow optimization
- Reviewed and approved hundreds of LIMS master data records and drove alignment on phase-appropriate data governance
- Optimized global Pest Control program, increasing compliance consistency and trending practices across functions
- Presented Analytical Method Validation project findings at VP and Director-level forums to support stakeholder engagement and QA process integration
Quality Engineer (Vertex Pharmaceuticals)
AM Life Science, On Assignment Lab Support
11.2015 - 06.2021
- Delivered QA oversight for facilities and engineering activities, including capital projects, annual plant shutdowns, facility certifications, equipment qualifications and lifecycle management, alarms management programs, periodic reviews, and systems validation and maintenance
- Validation Engineer (Brammer Bio, ThermoFisher, LFB, Genzyme Sanofi)
- Environmental Qualifications study director, shutdown study director
- CQV and IOQ authorship and execution
- Buffer tank cycle development, and small parts cleaning method and extended clean hold period validation
- Successful facility build-out for manufacturing space extension (Phase 3 at VMC, cleanroom builds at ThermoFisher and Genzyme) including validation design and execution of Vaporized hydrogen peroxide CQV program qualifying 6-log viral reduction capabilities.
- Successful QMS asset management module migration project from Maximo to Nuvolo CMMS for VMC and assistance with VCGT Providence including collaborative analysis and documentation of asset impact assessments, criticality assessments, calibration interval determination, maintenance requirements, and review and approval of eCRs for implementation of each asset
Senior Quality Control Associate
Bristol-Myers Squibb Company
02.2010 - 11.2015
- Department lead for Disinfectant Efficacy studies and Environmental Qualifications of Grade A, B, C, D, and CNC classified areas
- Supported use and validation of Autoclave systems via biological indicators
- Vendor coordination for instrument calibration, troubleshooting, and repairs
- Executed analytical techniques such as UV-Vis, HPLC, qPCR, and Bioburden and Endotoxin testing.
Education
Master of Science (MSc) - Pharmaceutical Chemistry
Graduate Certificate in Pharmaceutical Chemistry
Bachelor of Science (BS) - Biology
Minor in Chemistry
Skills
- VeeQMS
- VeeDMS
- Trackwise
- Veeva
- LIMS
- Nuvolo CMMS
- GTS-QUMAS
- ALM
- QC Data Review & Release
- OOS/OOT Investigations
- Root Cause Analysis
- CAPA Management
- Change Control
- Deviation Management
- Analytical Method Validation
- Quality Agreements
- Metrics & KPI Reporting
- Regulatory Inspection Support
- CGMP/GDP Compliance
- Lean Six Sigma Yellow Belt Certification
- Asana
- Microsoft Office Suite
- PowerBI
- Airtable
Career Achievements
- Change Management SME and Champion, leading 43% reduction in Change Control QA rejections and 50% faster review times through process optimization.
- Environmental Qualification Study Director for multiple high-impact GMP projects supporting facility and product readiness.
- Subject Matter Expert/Qualified Trainer for Aseptic Qualification and Methodology, Environmental Monitoring, QA Nuvolo, and Bulk Liquid Nitrogen QA Release.
- Key contributor for validation design and execution of Vaporized hydrogen peroxide CQV program qualifying 6-log viral reduction capabilities to protect against the potential risk for viral cross-contamination.
- Validation, Engineering, and Quality oversight advancing contamination control strategies that are aligned with evolving regulatory expectations including bulk nitrogen identity testing program development, pest control program optimization and procedural refinement, buffer tank cycle development supporting clean/dirty hold time studies, and assessments of spray ball coverage and temperature and volume parameters.
- Developed and executed program changes including EM Paperless Initiative which streamlined processes and increased efficiency by 32.5%, yielded time savings of 18.9 hours weekly, and decreased department costs.
Publications
Challenges in the use of in silico tools for predicting peptides binding to HLA-class II molecules of HCV E1, E2, and P7
- Dormer, A., Dacil, C., Pauleus, C. V., Sweson, M. N., Smiles, P. G., Challenges in the use of in silico tools for predicting peptides binding to HLA-Class II molecules of HCV E1, E2, and P7., In Silico Biology, 2010, https://pubmed.ncbi.nlm.nih.gov/22430440/
Languages
English
Native or Bilingual
French
Limited Working
Timeline
GMP Operational Quality Senior Specialist - Vertex Pharmaceuticals
06.2021 - Current
Quality Engineer (Vertex Pharmaceuticals) - AM Life Science, On Assignment Lab Support
11.2015 - 06.2021
Senior Quality Control Associate - Bristol-Myers Squibb Company
02.2010 - 11.2015
University of Florida - Master of Science (MSc), Pharmaceutical Chemistry
Atlantic Union College - Bachelor of Science (BS), Biology