- Over 15 years of regulated pharmaceutical software validation and quality experience, ensuring compliance with regulatory frameworks, industry guidance/ best practices, and internal regulatory policies.
- Substantial experience in implementing systems from conception to retirement, while providing innovative and sound guidance.
- Experienced with implementing coherent, and logical processes both locally and globally.
- Self - motivated team player that works effectively with cross functional teams on projects and organizational process improvement initiatives.
- Strong scientific and pharmaceutical business knowledge.
Laboratory software: Waters Millennium32 / Empower | Molecular Devices SoftMax | Applied Biosystems Analyst
LIMS: LabWare | LabVantage | Thermo Watson
Quality and support systems: Valgenesis | HP Quality Center | Livelink | Agilent OpenLAB
Compliance Director, San Francisco, CA
- Develop compliance policies to meet good engineering practices.
- Ensure adherence to policies by providing quality oversight of Confidential SaaS software applications.
- Oversee testing team to ensure compliance to established procedures.
- Provide external customer audit support, validation guidance for software used in a regulated healthcare SaaS model, and employee .
Senior Business Analyst, Berkeley, CA
- Validation lead for LabVantage LIMS upgrade (QC laboratory): Assessed business processes, developed validation strategy.
- Responsible for implementing changes for various systems, including MES.
- Provided guidance and reviewing quality management system procedures.
Senior Validation Engineer, San Francisco, CA
- Designed an integrated global computer system validation processes, including an integrated risk assessment, software development life cycle and retirement process; developed material and performed global .
- Provided QA support by reviewing and approving validation risk documentation, system related documentation, and test strategy documentation (SAP, TrackWise, Salesforce). Oversaw independent contractors.
- Responsible for administration and change management activities for Watson LIMS and SoftMax Pro.
- Validation projects included Applied Biosystems Analyst upgrade involving project management, oversight of contractors, vendors, movers, and quality assurance during instrument moves.
- Deployed Watson application to multiple sites via Citrix.
- Team member for a corporate initiative to in corporate GAMP.
Confidential, Rockville, MD
Laboratory Systems Administrator
- Validation lead responsible for the implementation of LabWare LIMS and Waters Millenium32 and Empower Client/Server, including authoring validation documents, standard operating procedures and materials.
- Laboratory system administrator responsible for change management of all lab computer systems.
- Coordinated activities across QA, IT and various business groups.
- Developed and validated analytical assay methods via HPLC, Dissolution, and UV-Vis.
- Performed product quality and excipient testing (GMP/GLP environment) in accordance with SOPs and the USP/NF.
- Calibrated and maintained laboratory equipment including HPLCs, Dissolution units, freezers, and stability chambers.