Product Disposition Senior Specialist, Quality

Overview

• Support the compliant disposition of pharmaceutical products across manufacturing stages, ensuring adherence to regulatory and quality standards.
• Review batch documentation and coordinate with internal and external stakeholders to facilitate timely product release.
• Execute quality system transactions using ERP platforms to maintain operational efficiency.
• Collaborate cross-functionally to address quality issues and ensure seamless product disposition processes.
• Maintain and develop Product Specification Files (PSF), ensuring accuracy and compliance.
• Escalate quality concerns and risks to management, contributing to proactive issue resolution.
• Operate effectively in a fast-paced, regulated environment with a commitment to quality excellence.
• Provide support for QA systems and related business processes to enhance operational effectiveness.

Key Responsibilities & Duties

• Conduct thorough reviews of batch documentation for investigational and commercial pharmaceutical products.
• Support disposition processes for diverse product types, including cell banks and finished goods.
• Coordinate QP batch certification activities and address related inquiries efficiently.
• Execute Quality Management System transactions to facilitate product release and compliance.
• Collaborate with Quality Control, Supply Chain, and Regulatory Affairs teams to ensure operational alignment.
• Escalate quality-related issues and risks to management, ensuring timely resolution.
• Assist in maintaining compliance with cGMP regulations and established quality systems.
• Support the implementation and maintenance of advanced eQMS systems for quality management.

Job Requirements

• Bachelor’s Degree in science, engineering, or a related discipline is required.
• Minimum of 5 years’ experience in GxP-regulated pharmaceutical or biotechnology environments.
• Proven experience in product disposition, batch record review, or QA operations is preferred.
• Familiarity with cGMP regulations and quality systems in US/EU contexts is essential.
• Proficiency with ERP systems such as Oracle is highly desirable.
• Strong organizational, communication, and problem-solving skills are required.
• Ability to manage multiple priorities independently in a dynamic environment.
• Experience with Veeva eQMS systems is considered a valuable asset.