QA Senior Specialist (Disposition)

Responsibilities

• Review and approve GMP manufacturing batch records and related quality documentations.
• Responsible for ensuring all material qualification activities are completed and documented prior to use in GMP manufacturing
• Approve or reject batches based on established specifications, SOPs and regulatory requirements.
• Collaborate with Procurement, QC, Warehouse and Manufacturing to maintain qualified supplier and material status.
• Collaborate with QA and manufacturing teams to resolve discrepancies, deviations, and CAPAs prior to disposition.
• Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
• Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
• Support both internal and external audits.
• Carry out additional tasks as assigned by leadership.

Requirements

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• 5-10 years of relevant QA experience (preferably in Lot Disposition) in Biopharma or Pharmaceuticals industry
• Familiar with FDA, EMEA, and PICS GMP requirements.
• Knowledgeable in biological product manufacturing and related quality control requirements.
• Experience with a new site start-up is preferred.
• ADC manufacturing and quality management experience is a plus.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, etc.
• Strong learning ability.
• Excellent cross-functional communication and collaboration skills.
• Strong logical thinking and conflict management abilities.
• Demonstrates strong ownership.

Additional Information

Job Summary Responsible for overseeing timely and compliant disposition of GMP materials and products, ensuring adherence of critical quality attributes to applicable internal procedures and regulatory requirements.

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Company Intel

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