MBX Biosciences, Inc. · 23 hours ago
Quality Operations Specialist
United States
Full-time
Remote
Mid Level
3+ years expMBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. The Quality Operations Specialist will ensure the accuracy and compliance of batch production records, collaborating with various teams to resolve issues and support investigations related to batch record deviations.
BiotechnologyHealth CareTherapeutics
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
Qualification
Required
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
MBX Biosciences, Inc.
MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs™).
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$238.4MKey Investors
Deep Track CapitalWellington ManagementFrazier Healthcare Partners
2024-09-13IPO
2024-08-05Series C· $63.5M
2022-11-14Series B· $115M
Leadership Team
P. Kent Hawryluk
President & CEO
Michelle Graham
Chief Human Resources Officer
Recent News
legacy.thefly.com
2026-01-23
2026-01-22
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2026-01-16
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