Quality Operations Specialist – External Manufacturing

Job Description:

Responsibilities

• Review external GMP batch documentation from CDMO partners for completeness, accuracy, and compliance with approved manufacturing and regulatory requirements.
• Evaluate analytical data, Certificates of Analysis (CoA), and laboratory documentation to ensure data integrity and GMP compliance.
• Support Quality oversight of external manufacturing activities, including preparation for batch disposition.
• Identify documentation inconsistencies, deviations, and potential compliance risks, ensuring timely escalation to Quality stakeholders.
• Collaborate with internal teams (QA, QC, Supply Chain) and external CDMO partners to resolve documentation queries and ensure alignment.
• Generate and maintain Key Quality Indicators (KQIs) to monitor external manufacturing quality performance.
• Ensure adherence to Lonza Quality Standards, data integrity principles, and global/local GMP regulations.

Qualification & Expeirence

• Bachelor’s degree in Chemistry, Biotechnology, Pharmaceutical Sciences, or related field.
• Experience in GMP-regulated pharmaceutical, biopharmaceutical, or CDMO environments is advantageous.
• Understanding of GMP documentation, batch records, and data integrity requirements.