Quality Assurance Specialist – Sterile Manufacturing

Title: Quality Assurance Specialist – Sterile Manufacturing

Experience: 5–8 years

The Quality Assurance Specialist will provide hands-on quality oversight for sterile manufacturing operations, with a primary focus on aseptic vial filling and fill-finish activities. This role ensures compliance with cGMP, FDA regulations, and internal quality systems while supporting manufacturing excellence and inspection readiness.

• Provide QA oversight for aseptic vial filling, stoppering, and capping operations.
• Review and approve batch records related to sterile manufacturing and fill-finish activities.
• Support and manage deviations, investigations, CAPA, and change controls associated with vial filling processes.
• Ensure compliance with cGMP, GDP, FDA regulations, and internal quality standards.
• Participate in internal audits, regulatory inspections, and quality risk assessments.
• Collaborate with Manufacturing, Engineering, and Validation teams to maintain inspection readiness and continuous compliance.

• 5–8 years of Quality Assurance experience in sterile or injectable pharmaceutical manufacturing.
• Direct QA support experience for aseptic vial filling and fill-finish operations.
• Strong working knowledge of cGMP and FDA regulations.
• Proven experience reviewing batch records and managing quality events related to sterile manufacturing.