QA Associate — GMP, Sterility & CAPA Lead

Integra LifeSciences Corporation; Indiana (PA); On-site; USD 70,000 - 100,000; Full time

Job summary

Integra LifeSciences Corporation seeks an Associate Quality Assurance professional to lead nonconformance investigations and CAPA within GMP-regulated environments. You will support manufacturing operations, collaborate with cross-functional teams, and drive sterility assurance programs to uphold patient safety and product quality.

The role emphasizes leadership, regulatory knowledge, and strong communication to navigate FDA/EMA expectations and continuous improvement initiatives across aseptic

Qualifications

• Bachelor’s degree in a related field.
• 5+ years of QA experience in pharma/biotech/medical devices.
• Experience with nonconformance investigations, CAPA, and GMP regulations.
• Knowledge of aseptic processing and sterility assurance principles.
• Strong leadership, problem-solving, and communication skills.
• Familiarity with FDA, EMA, and international regulatory requirements.
• Fluent in French and English.

Responsibilities

• Oversee nonconformance management: identify, document, investigate, and close events with root-cause analysis and CAPA.
• Provide QA oversight to manufacturing operations and support cross-functional teams to resolve quality issues.
• Oversee sterility assurance programs for aseptic manufacturing and ensure compliance with global regulatory requirements.
• Lead and mentor QA personnel, support internal audits and regulatory inspections, and promote a culture of quality.

Skills

Leadership

Problem-solving

Communication

Fluent in French

Fluent in English

GMP Regulations

Education

Bachelor's degree in Biology/Microbiology/Chemistry/Pharmaceutical Sciences/Engineering

Job description

Integra LifeSciences Corporation seeks an Associate Quality Assurance professional to lead nonconformance investigations and CAPA within GMP-regulated environments. You will support manufacturing operations, collaborate with cross-functional teams, and drive sterility assurance programs to uphold patient safety and product quality.

The role emphasizes leadership, regulatory knowledge, and strong communication to navigate FDA/EMA expectations and continuous improvement initiatives across aseptic