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 review of internal documents and records.• Leads the planning and implementation of efficient, phase-appropriate quality management systems for companies in the pre-clinical and early clinical stages.• Facilitates remediation discussions and develops formal remediation plans to ensure efficient and effective remediation of audits and gap assessments.• Promotes continuous improvement initiatives and mindset, including developing tools for visualization of training compliance and resource scheduling.• Develops polished procedures, master batch records, reports, specifications, risk assessments, gap assessments, audit storyboards, and other technical documents in accordance with federal regulations, internal procedures, and industry best practice.• Provides regular updates to relevant stakeholders to facilitate timely decision-making and appropriate prioritization of activities.• Supports quality and compliance service offerings for clients as a technical resource, project manager, and client liaison.• Supports the development of SOWs and proposals, including planning activities, deliverables, schedule, and resources.

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 clinical and commercial single-use manufacturing for gene therapy.o Primary SME for cell expansion, 50L RM Bioreactor, visual inspection, depth filtration.o Trained new hires in aseptic technique and the intricacies of the manufacturing process.o Performed regular logbook and batch record reviews to ensure GDP / GMP compliance.o Collaborated frequently with manufacturing specialists and support groups.o Proposed and authored multiple GxP forms to ensure that all areas of the process are effectively documented and fully compliant with FDA standards.o Participated in smoke studies for BSC performance qualifications.o Completed training for deviations, change controls, and CAPAs.o Troubleshoots potential and emerging process and equipment-related issues in-the-moment during engineering runs.o Performs regular aseptic operations inside a BSC for cell expansion and transfection. o Actively contributes to company culture with a “patients first” mindset.