Senior Qa

Kyndryl Brasil Serviços Limitada; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A global biopharmaceutical company in São Paulo is seeking a Specialist in External Quality Assurance (EQA) to oversee Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories. This role is essential for ensuring compliance with cGMP and resolving quality events. The ideal candidate has a Bachelor's degree in Life Sciences and 3-5 years of QA experience in the biopharmaceutical sector. Excellent communication and problem-solving skills are vital for this role, which supports ongoing manufacturing campaigns and regulatory inspections.

Qualificações

• 3 - 5 years of QA experience in the biopharmaceutical or cell/gene therapy industry.
• Experience with CDMO oversight, lot release, and deviation management.

Responsabilidades

• Provide oversight of CDMOs and testing labs to ensure compliance with cGMP.
• Review and approve deviations, OOS investigations, CAPAs, and change controls.
• Monitor manufacturing campaigns and production activities.

Conhecimentos

Strong knowledge of cGMP

Excellent communication

Problem-solving skills

Formação académica

Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline

Descrição da oferta de emprego

Specialist, External Quality Assurance (EQA)

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.

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.

Full Quality Assurance Analyst

• Giving support for executing and ensuring quality during all processes in MSN Brazil.
• Maintain a standardized methodology that ensures the quality of processes of the product and company.
• Giving support to the involved areas on the execution of tests and internal certification of products to ensure quality standards and that proper functioning are met.
• Register and keep the information updated to avoid deviations in the defined quality parameters, agreeing preventive and corrective actions with the responsible for QA department.
• Maintain documents and plans updated (Incident, Notification, nomination, CAPAs, Deviation, Training, SOPs, etc), verifying the validity of registration, permits, among others.
• Support QA department responsible for Internal Audits, as part of the control and monitoring process.
• Monitoring of analytical quality assurance activities.
• Review and close the quality control log books.
• Review of instrument qualification documents and calibration records.
• Review of electronic data records.
• Review of deviation investigation reports, OOT and OOS.
• Review specifications and test methods as appropriate.
• Responsible for opening / giving number of Incident, Notification, nomination, CAPAs,
• Supporting and ensures the continuity of the policies, processes and procedures of all compliance management systems.
• Carry out self‑inspections together with the responsible for the QA department.
• Review of method validation, method verification and method transfer documents.
• Giving support on the analyses and actions plan for the resolution of Non‑Conformities.
• Responsible for preparing the documentation for new employees, ensuring training on the applicable SOPs.
• Review of batch audit trails.