Senior QA Specialist – Sterilization Excellence (Onsite)

B. Braun; Irvine (CA); On-site; USD 115,000 - 140,000; Full time

Job summary

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA, is seeking a Senior QA Specialist – Sterilization to provide quality and technical expertise in sterilization and microbiology activities supporting manufacturing and laboratory operations.

The role leads validation and revalidation of sterilization equipment and processes, develops strategies, reviews protocols, and ensures compliance with FDA regulations, ISO standards, and quality systems while collaborating with Quality,

Qualifications

• Bachelor’s degree in microbiology, biology, engineering, life sciences or a related technical discipline.
• Minimum 8 years of related experience in QA, sterilization, microbiology or validation in a regulated manufacturing environment.
• Experience with sterilization process validation/revalidation and validation protocols, reports and plans.
• Working knowledge of FDA regulations, ISO standards and quality system requirements.
• Strong technical writing, problem-solving, communication and cross-functional collaboration.
• Ability to travel occasionally and maintain regular attendance.

Responsibilities

• Provide Quality oversight and technical guidance for sterilization activities to maintain product and process compliance.
• Lead validation and revalidation of sterilization equipment, methods and products.
• Develop validation strategies and master plans, manage schedules, and author, review and approve protocols and reports.
• Resolve complex sterilization and microbiology issues using sound scientific and quality judgment.
• Ensure compliance with company procedures, FDA regulations, applicable ISO standards and Canadian Medical Device Regulations, where applicable.
• Partner with internal teams and external contractors/vendors, and provide technical guidance or training to less-experienced employees.

Skills

Quality oversight

Sterilization expertise

Cross-functional collaboration

Technical writing

Problem-solving

Travel readiness

Education

Bachelor’s degree in microbiology/related

Master’s degree preferred

Job description

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA, is seeking a Senior QA Specialist – Sterilization to provide quality and technical expertise in sterilization and microbiology activities supporting manufacturing and laboratory operations.

The role leads validation and revalidation of sterilization equipment and processes, develops strategies, reviews protocols, and ensures compliance with FDA regulations, ISO standards, and quality systems while collaborating with Quality,