External Quality Assurance Lead
1 dia atrás
Job Title: External Quality Assurance Specialist We are seeking a highly skilled External Quality Assurance Specialist to provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories. 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. Required Skills and 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.
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Specialist - External Quality Assurance
Há 4 dias
São Paulo, SP, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist - External Quality Assurance
Há 2 dias
São Paulo, SP, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist - External Quality Assurance
Há 2 dias
São Paulo, SP, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist - External Quality Assurance
1 dia atrás
São Paulo, SP, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist - External Quality Assurance
Há 22 horas
São Paulo, Brasil Nexcella, Inc. Tempo inteiroSpecialist – External Quality Assurance São Paulo, Brazil / RemoteNexcella, Inc.Our 3 Core Values• Intelligence• Integrity• InitiativeOur 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...
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Specialist – External Quality Assurance
Há 3 dias
São Paulo, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist – External Quality Assurance
Há 3 dias
São Paulo, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist - External Quality Assurance
Há 3 dias
São Paulo, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist – External Quality Assurance
1 dia atrás
São Paulo, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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...
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Specialist - External Quality Assurance
1 dia atrás
São Paulo, Brasil Nexcella, Inc. Tempo inteiroSpecialist – 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)...
