Quality Assurance Lot Disposition

ot Disposition Specialist

Responsible for reviewing, evaluating, and approving the disposition of manufactured lots of raw materials, in-process materials, and finished products in compliance with cGMP, company policies, and regulatory requirements. Ensures all lots released for distribution or further processing meet established quality standards and are fully documented.

Key Responsibilities

• Review batch records, laboratory test results, and deviation reports to determine lot disposition status.
• Evaluate non-conformances, out-of-specification (OOS) results, and deviations to provide disposition recommendations.
• Coordinate with Quality Assurance, Manufacturing, and Regulatory teams to ensure timely and compliant lot disposition activities.
• Maintain accurate documentation and ensure approvals are properly recorded in the Quality Management System (QMS).
• Participate in investigations related to lot quality issues and support root cause analysis, CAPA, and deviation management processes.
• Ensure compliance with cGMP requirements, SOPs, FDA, EMA, and other applicable regulatory standards.
• Support continuous improvement initiatives to enhance disposition processes, compliance, and operational efficiency.
• Utilize strong analytical, problem-solving, and communication skills to support cross-functional quality operations.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or a related field.
• 2+ years of experience in pharmaceutical or biopharmaceutical manufacturing, quality operations, or batch review.
• Working knowledge of cGMP regulations, FDA/EMA requirements, and quality systems.
• Strong attention to detail with excellent analytical and problem-solving abilities.
• Effective communication and collaboration skills in a cross-functional environment.
• Proficiency with electronic QMS systems and Microsoft Office Suite.

Preferred Qualifications

• Experience with lot disposition or batch review in a biopharmaceutical environment.
• Familiarity with investigations, CAPA, deviation management, and quality event processes.