Quality Assurance Specialist Product Disposition

Job Title: Product Disposition Sr. Specialist, Quality Assurance

Location: Massachusetts (Onsite)

Employment Type: Contract

Seeking a Product Disposition Sr. Specialist, Quality with experience in product disposition, batch record review, and QA operations within a GMP-regulated pharmaceutical or biotechnology environment. The role will support the compliant and timely disposition of products across all manufacturing stages while ensuring adherence to quality and regulatory requirements.

• Bachelor's degree in Science, Engineering, or related discipline
• 5+ years of experience in a GxP-regulated pharmaceutical or biotechnology environment
• Experience with product disposition, batch record review, or QA operations
• Knowledge of cGMP regulations and quality systems (US/EU)
• Experience with Oracle or similar ERP systems
• Strong organizational, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment

• Perform detailed review of batch documentation for investigational and commercial products
• Support disposition activities for cell banks, viral banks, plasmids, drug substance, drug product, and finished goods
• Coordinate QP batch certification activities, including documentation preparation and responses to queries
• Execute and maintain quality management transactions in Oracle to support product release
• Support development and maintenance of Product Specification Files (PSF)
• Collaborate with Quality Control, Supply Chain, Regulatory Affairs, and Technical Operations teams
• Escalate quality issues and risks to management as needed
• Support QA systems and related business processes

• Experience with Veeva eQMS
• Experience supporting commercial and investigational product release activities
• Strong cross-functional collaboration skills in regulated manufacturing environ