Quality Operations Specialist

Role Summary

Quality Operations Specialist at MBX Biosciences. Focused on ensuring accuracy, completeness, and compliance of batch production records within a GMP-regulated pharmaceutical/biotech manufacturing environment. Reports to the Head of Quality Operations.

Responsibilities

• Review and approve production batch records for completeness, accuracy, and compliance with cGMP and internal SOPs.
• Identify and escalate discrepancies, deviations, or documentation errors found during batch record review.
• Collaborate with the CMC team and other departments to resolve batch record issues and ensure timely release of product.
• Support investigations related to batch record deviations, including root cause analysis and CAPA development.
• Aid with requests relating to QP release.
• Maintain and update batch record review templates and ensure alignment with current processes and regulatory expectations.
• Participate in internal audits and support external inspections by regulatory agencies.
• Assist with GMP assigned training.
• Contribute to continuous improvement initiatives related to documentation practices and quality systems.
• Other responsibilities as assigned.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field.
• 3+ years of experience in a GMP-regulated environment, preferably in batch record review or quality assurance.
• Strong understanding of FDA, EMA, and ICH guidelines related to documentation and manufacturing practices.
• Excellent attention to detail and ability to work independently with minimal supervision.
• Proficient in Microsoft Office and electronic document management systems.