Carol Finnie Email & Phone Number

Rockville, MD

Summit, NJ

Quality, Data Integrity, Process Improvement, Audits, Correction Action (CAPAs and DEVs)As a Data Integrity Champion, represented IT on Global and Local Data Integrity initiatives. Performed gap assessments for site wide GMP instrumentation and enterprise systems that resulted in an increase in data integrity compliancy by over 50%. Liaised with cross.

Summit, NJ

Project managed a global enterprise scientific asset management (Blue Mountain RAM), Electronic Notebook (e-notebook) and Waters EMPOWER systems that resulted in simplified work flows, asset centralization, upgrading of instruments and software. Responsible for creating, planning, and execution. Ensured that project meet deadlines by allocating resources.

Designed and built newly formed lab systems engineering department. Individually completed recruitment, negotiation, hiring of staff and contractors. Evolved services into a truly integrated, enterprise level offering, suitable for growing biotech company. Ensured alignment of site resources with IT and business strategy. Won approval for a $250K project.

Bridgewater, NJ

• Responsible for many facets of IS department with regional and global customers.Major accomplishments include:
• Drove IT North American R&D Lab Equipment Maintenance consolidation project of over 5000 scientific instruments that resulted in $2MM annual reduction in spending.
• Actively involved in project lifecycle, which included vendor selection, contract negotiation, SOW, writing RFPs, performing site audits, leading monthly IT meetings, and evaluation of instrument inventory and service.

Bridgewater, NJ

• Managed several internal projects concurrently, with business, Information Systems, and outside vendors. Interfaced with customers, various IT departments, and vendors on critical issues and projects pertaining to.
• Managed the integrations of third party applications into the lab services environment. Coordinated efforts to ensure uninterrupted scientific research time by maintaining over 120 lab instruments workstations with.
• Served as a lab expert lead on global and regional teams to identify lab workstation gaps, root cause and support corrective action
• Worked within sanofi standards, best practices, and regulated environments to design, to test, implement, document, and validate computerized systems
• Assured comprehensive GxP and IS compliance oversight and governance by performing site audits, preventative maintenance, writing IQs, OQs, SOPs, initialized and approved change controls
• Diagnosed regional issues and made recommendations for improving work flow efficiency including business processes and systems and mitigating risk

Mba, Computer Applicaitons

Bs, Biology And Computer Science