Quality Operations Specialist

Position Summary

MBX Biosciences is seeking detail-oriented and highly organized Quality Operations Specialist to join our growing Quality Assurance team. This role is critical in ensuring the accuracy, completeness, and compliance of batch production records in accordance with internal procedures, regulatory requirements, and industry standards. Reporting to the Head of Quality Operations, the ideal candidate will have a solid background in GMP documentation, batch record review, and quality systems within a pharmaceutical or biotech manufacturing environment.

Key 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 MBX 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.

Education & 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.

Company Overview

MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs, and large potential market opportunities. The Company’s pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

EEO Statement:

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.