Description

ITF Therapeutics is seeking a temporary contractor for a Senior Specialist, Quality Assurance position on our Quality team. The role supports the daily operations of the deviation, CAPA, Change Control, and Product Complaints.

ITF Therapeutics is dedicated to providing new therapeutic options for individuals with rare diseases. It is the US division of Italfarmaco S.p.A., a private global pharmaceutical company founded in 1938 in Milan, Italy. Italfarmaco has successfully developed numerous innovative therapeutic products approved for patients worldwide.

Role Responsibilities:

• Manages the receiving and handling (intake, triage, follow-up, product returns, investigation, and reconciliation,) of Product Quality Complaints in a manner that complies with global regulatory requirements.
• Supporting users with investigations/deviations, CAPA, and change controls programs, including final review and approval
• Ensure thorough root cause evaluation and implementation of effective corrective actions.
• Facilitate Quality Risk Assessments
• Support audits of service providers
• Provides assistance to the front and back rooms during cGMP compliance inspections
• Provides organizational training and support.
• Supports computer system validation efforts for implementing changes to the eQMS
• Identify and implement continuous improvement opportunities
• Support the Quality Management Review
• Regularly generate metrics and communicate (e.g., trends, process) for their effectiveness and provide feedback to the Quality Systems team for action and remediation.
• Maintain compliance with applicable regulatory and company documentation standards.
• Actively collaborate with QC, Manufacturing, Regulatory, and Supply Chain functions.
• Ability to navigate, integrate, and troubleshoot cross-platform data for QA use cases.
• Completes assigned training on-time
• Other duties as assigned.

Requirements

• Bachelor's degree in a science, technology, engineering, or mathematics.
• Bachelors degree in a STEM field with 3-5 years of industry experience.
• Experience supporting CAPA, Deviations/Investigations, Change Controls, and/or Product Complaints processes as a quality partner.
• Experience working with manufacturing sites and 3PLs in a Quality oversight role
• Knowledge of cGMPs
• Proactive in identifying opportunities with a robust solution-minded approach and flexibility to emerging challenges.
• The ability to comprehend regulations and guidance documents, apply critical thinking skills to evaluate requirements, and effectively communicate written and oral findings.