Amy Fearnside Email & Phone Number

New York, New York, US

Morrisville, North Carolina, US

• Builds positive relationships with clients in the life sciences industries while identifying, designing, and implementing scalable, fit-for-purpose solutions.
• Dynamically engages with clients to ensure proposed solutions satisfy client specifications and relevant industry standards and regulations.
• Successfully communicates with and mediates for clients of all personalities, leading to communication breakthroughs, successful project delivery, and repeat customers.
• Supports eQMS implementation, customization, and validation, including migration from previous electronic or paper-based systems.
• Educates clients on relevant industry standards and regulations, such as 21 CFR 4, 11, 58, 210, 211, 312, 600, and 820, and ensures adherence through the completion of gap assessments, internal and supplier audits, and.
• Leads the planning and implementation of efficient, phase-appropriate quality management systems for companies in the pre-clinical and early clinical stages.

Somerville, Massachusetts, US

o Hands-on experience with single-use manufacturing for upstream and downstream processing.o Worked closely with specialist to build the visual inspection program and procedures.o Conducted deviation investigation with root cause analysis, impact analysis, and CAPA.o Developed and refined procedures during startup phase and all engineering runs for.