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Cabaletta Bio · 12 hours ago

GMP QC Specialist, CMC

Philadelphia, PA

Full-time

Hybrid

Senior Level

5+ years exp

Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. The GMP QC Specialist, CMC will ensure compliance of QC data with Good Manufacturing Practices and work closely with cross-functional teams to enhance quality systems.

BiotechnologyHealth CareMedicalRoboticsTherapeutics

Responsibilities

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

Qualification

GMP complianceMicrobiological assaysQuality Control proceduresBiopharmaceutical operationsAssay qualificationRegulatory requirementsTeam orientationContinuous improvementEffective communication

Required

Bachelor's degree in scientific discipline

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)

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