Specialist – External Quality Assurance

Há 2 dias

Brasília, Brasil Nexcella, Inc. Tempo inteiro

Specialist – External Quality Assurance São Paulo, Brazil / Remote Nexcella, Inc. Our 3 Core Values - Intelligence - Integrity - Initiative Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting What You'll Do: The Specialist, External Quality Assurance (EQA) will provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role is critical in supporting ongoing manufacturing campaigns, batch release, and ensuring timely resolution of quality events. What We Look For: Key Responsibilities Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories. Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing. Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs. Review and approve production lot records for compliance prior to disposition. Perform GMP reviews of incoming documentation (batch records, test data, release packages). Ensure timely escalation and resolution of manufacturing and quality issues. Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings. Support audit readiness activities for Regulatory Authority inspections. Qualifications Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline. 3 - 5 years of QA experience in the biopharmaceutical or cell/gene therapy industry. Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211. Experience with CDMO oversight, lot release, and deviation management. Excellent communication and problem-solving skills. About Nexcella, Inc. Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that filters out non-specific activation. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT ), with a registrational design. Interim results were presented at ASCO 2025. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and

  • External Quality Assurance Lead

    Há 8 horas

    Brasília, DF, Brasil beBeeQuality Tempo inteiro

    External Quality Assurance Specialist About the Role: The External Quality Assurance (EQA) Specialist will provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role is critical in supporting ongoing manufacturing...

  • Automation Quality Assurance Specialist

    1 semana atrás

    Brasília, Brasil beBeeQuality Tempo inteiro

    Automation Quality Assurance Specialist We are seeking an experienced automation quality assurance specialist to work remotely with a global leader in technology and engineering services. This is a long-term position in the quick serve restaurants industry. The end client operates within the US Pacific Time Zone. A minimum of 10 years of quality...

  • Data Quality Assurance Specialist

    4 semanas atrás

    Brasília, Brasil beBeeDataQuality Tempo inteiro

    Data Quality Assurance Specialist Job Description Duties and Responsibilities: We are seeking a highly skilled Data Quality Assurance Specialist to join our team. The ideal candidate will have experience in data quality assurance, testing, and analysis. Key Activities: Design and implement effective quality control processes to ensure high-quality data...

  • A Great Opportunity for Growth as a Quality Assurance Specialist

    Há 8 horas

    Brasília, DF, Brasil beBeeQuality Tempo inteiro

    Transform Your Career as a Quality Assurance Specialist Come and be part of a leading IT services company where you can grow your career to new heights. We believe that people make the difference, so we foster a culture of unlimited learning, full of opportunities for growth and mutual development. We are looking for a Quality Assurance Specialist who wants...

  • Language Quality Assurance Specialist

    4 semanas atrás

    Brasília, Brasil beBeeQuality Tempo inteiro

    Language Quality Assurance Specialist This is an entry-level, fully remote position in our international legal translations division. Collaborate with the Project Management team to clarify project objectives and parameters. Perform quality assurance checks on translated documents. Communicate effectively with vendors worldwide to reconcile errors in...

  • Quality Assurance Engineer

    2 semanas atrás

    Brasília, Distrito Federal, Brasil Jobluno Tempo inteiro US$41.000 - US$90.000 por ano

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for a Quality Assurance Engineer based in the Federal District, Brazil. The Quality Assurance Engineer will be responsible for designing and executing test cases, conducting manual and software testing, ensuring quality assurance processes, and reporting...

  • Senior Quality Assurance Analyst

    2 semanas atrás

    Brasília, Brasil Laboratorios Biopas Tempo inteiro

    Position: Senior Quality Assurance Analyst – Pharmaceutical Industry Location: Vargem Grande Paulista, São Paulo, BrazilWork Model: 100% On-sitePosition DescriptionWe are seeking a Senior Quality Assurance Analyst to work on-site at our facilities, with a primary focus on Validation/Qualification, Quality, and Compliance.The ideal candidate will have...

  • Quality Assurance Specialist

    2 semanas atrás

    Brasília, Brasil Tata Consultancy Services Tempo inteiro

    Come to one of the biggest IT Services companies in the world!! Here you can transform your career! Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing...

  • Quality assurance specialist

    3 semanas atrás

    Brasília, Brasil Tata Consultancy Services Tempo inteiro

    Come to one of the biggest IT Services companies in the world!! Here you can transform your career! Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing...

  • Senior Quality Assurance Analyst

    2 semanas atrás

    Brasília, Brasil Laboratorios Biopas Tempo inteiro

    Position : Senior Quality Assurance Analyst – Pharmaceutical Industry Location : Vargem Grande Paulista, São Paulo, Brazil Work Model : 100% On-site Position Description We are seeking a Senior Quality Assurance Analyst to work on-site at our facilities, with a primary focus on Validation / Qualification, Quality, and Compliance. The ideal candidate will...