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GMP QC Specialist, CMC

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Cabaletta Bio Inc

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Location:
United States , Philadelphia

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be responsible for ensuring the compliance of generated QC data with Good Manufacturing Practices (GMP) both within the organization and generated by third parties. The individual will be involved in developing, implementing, and maintaining Quality Control review processes to uphold the highest standards in internal and external laboratory activities. The role will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant internal and regulatory requirements.

Job Responsibility:

  • GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
  • Batch Review / Release: Perform full batch record review of all types of investigations
  • perform appropriate quality control review of all QC data generated by third parties
  • draft, review, and approve CoA (internal/external)
  • Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
  • Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
  • Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
  • Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
  • Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
  • Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures
  • Risk Management: Identify and assess potential risks related to GMP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues
  • Continuous Improvement: Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality
  • Communication: Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements to Quality Management

Requirements:

  • Bachelor’s degree in scientific discipline
  • Advanced degree preferred
  • Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
  • Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
  • Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
  • Experience interacting with external testing laboratories preferred
  • Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
  • Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
  • Strong team orientation and passion for continuous self-development
  • Experience in industry or in a startup industrial setting is preferred

Nice to have:

  • Advanced degree preferred
  • Experience interacting with external testing laboratories preferred
  • Experience in industry or in a startup industrial setting is preferred
What we offer:
  • health and retirement
  • PTO
  • stock option plans

Additional Information:

Job Posted:
December 06, 2025

Work Type:
Hybrid work
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