Senior Quality Operations - Biologics & Gene Therapy

Valid8 Financial, Inc.; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Ascend Advanced Therapies seeks a Senior Quality Specialist, Quality Operations to provide end-to-end QA support for the manufacture and release of gene therapies and other biologics in a GMP setting. You will collaborate with Manufacturing, QC, and cross-functional teams to ensure compliance with FDA, EU, and ICH standards.

The ideal candidate brings strong GMP quality experience in biologics, cell or gene therapy manufacturing and can apply regulatory requirements to complex operations while

Qualifications

• BS in Life Science or equivalent
• 5+ years in regulated pharma
• GMP biologics experience preferred

Responsibilities

• Review and approve master batch records and related QA documentation.
• QA on the Floor and Room Release activities.
• Draft/approve Certificates of Analysis and Certificates of Compliance.
• Act as QA representative in client meetings and regulatory discussions.
• Lead CAPA and Change Control plans.
• Perform internal and external audits and supplier audits.
• Assist with trend analysis and continuous quality improvements.
• Interface with contract testing organizations to resolve quality issues.
• Host client audits and regulatory inspections.

Skills

GMP Quality

Biologics

CAPA

Change Control

Audits

Investigations

Regulatory Compliance

Cross-functional

Education

BS in Life Science

Associate's Degree

Job description

Ascend Advanced Therapies seeks a Senior Quality Specialist, Quality Operations to provide end-to-end QA support for the manufacture and release of gene therapies and other biologics in a GMP setting. You will collaborate with Manufacturing, QC, and cross-functional teams to ensure compliance with FDA, EU, and ICH standards.

The ideal candidate brings strong GMP quality experience in biologics, cell or gene therapy manufacturing and can apply regulatory requirements to complex operations while