Senior Consultant

• Aug 2021 - Present

Technical transfer of a new product assay to Operations - responsible for ensuring procedures, systems, and processes in place for validation and product transfer. Cross functional coordination. Technical transfer of a new product assay to Operations - responsible for ensuring procedures, systems, and processes in place for validation and product transfer. Cross functional coordination.

Semi Retired

• Jan 2021 - Aug 2021

Principal Scientist

• Jul 2018 - Jan 2021

Managed the transfer of new assays from R&D to manufacturing within the Product Development Lifecycle Process. Involved working cross functionally across many departments including Regulatory and Quality. Ensured balance between operational and assay capability. As required, responsible for system, manufacturing process, method, and/or equipment validation pre validations to support new assays. Ensured procedures were updated or created as required. Ensured SAP, LIMS set up for new product. Responsible for control plans and setting and monitoring post launch metrics. Show less

Product Support Staff Scientist

• Mar 2018 - Jun 2018

Transfers new assays and platforms from R&D to Manufacturing. Key Skills: Validation, Project Management, Document Control, Control Plans, Cross functional Collaboration

Quality Lab Lead

• Jan 2015 - Mar 2018

Lead a 24/5 production team for the Analytical Chemistry LabProject Management Lead for a current LIMS system software changes required for a new product release.Project Management Lead for a Lab Consolidation between two sites, combining into one site with process improvements and lean lab design.Skills: Changing priorities, continuous improvement, project management, validation, CAPA, management, people development.Systems: 2 types of LIMS, SAP, CAPA management (QERTS), Document Management Show less

Quality Assurance Team Lead

• Jan 2013 - Dec 2014

Led a cross site lab team - Analytical laboratory, Fluids Release laboratory, and Microbiology Lab plus validation engineering support for a new LIMS system implementation. Responsible for people management, CAPA, validation, continuous improvement projects, and product release.

Quality Team Lead

• May 2011 - Dec 2012

Responsible for leading a high performing team that performs Quality Assurance review and release of in-process and final product.Responsible for Nonconformance and CAPA management.Validation Engineer support for manufacturing and release process changes.Greenbelt Process Excellence certified

Quality/Validation Engineer

• Jan 2004 - Apr 2011

New Product and Capital Equipment Validation – authored user requirements, validation plans, reports, worked with equipment engineers to ensure compliance, approved executed protocols using GAMP, Agile, and Waterfall methods.Managed CAPA, Non Conformances, and Audit Observations. Report metrics to management and held quality reviews.Conducted informal internal audits and worked in backroom for formal internal/external audits.

Quality Assurance Analyst

• Jun 1981 - Jan 2004

MISC (1981-2004) - Technician, Quality Analyst I, II, IIIHeld laboratory positions increasing in responsibility and knowledge in environmental, industrial hygiene, clinical chemistry, reference lab, and product release.Technical lead for a LIMS implementation project requiring travel to Germany, working across multiple groups in replacement of an obsolete VAX system. Involved user requirements, risk management, validation, training program creation, and supplier auditing.