Quality Assurance Specialist

Intellectt Inc; Town of Florida (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

A pharmaceutical company in New York is seeking a Quality Assurance Specialist for sterile manufacturing. This role involves providing oversight for aseptic vial filling and ensuring compliance with cGMP and FDA regulations. Ideal candidates should possess 5–8 years of relevant experience and strong skills in documentation and problem-solving. Join a team committed to quality and compliance in manufacturing processes.

Qualifications

• 5–8 years of Quality Assurance experience in sterile or injectable pharmaceutical manufacturing environments.
• Direct QA experience supporting aseptic vial filling and fill-finish operations.
• Strong working knowledge of cGMP and FDA regulations.

Responsibilities

• Provide QA oversight for aseptic vial filling, stoppering, and capping operations.
• Review and approve batch records associated with sterile manufacturing.
• Support and manage deviations, investigations, CAPA, and change controls.

Skills

Quality Assurance experience

Knowledge of cGMP and FDA regulations

Documentation skills

Communication skills

Problem-solving skills

Job description

Job Title: Quality Assurance Specialist – Sterile Manufacturing

Location: FL (Onsite)

Duration: 12 Months

Overview

The Quality Assurance Specialist will provide quality oversight for sterile manufacturing operations, with a primary focus on aseptic vial filling and fill-finish activities. This role ensures that manufacturing processes comply with cGMP requirements and internal quality systems while supporting inspection-ready operations.

Responsibilities

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

Qualifications

• 5–8 years of Quality Assurance experience in sterile or injectable pharmaceutical manufacturing environments.
• Direct QA experience supporting aseptic vial filling and fill-finish operations.
• Strong working knowledge of cGMP and FDA regulations.
• Experience reviewing batch records and managing quality events related to sterile manufacturing.
• Strong documentation, communication, and problem-solving skills.