Senior QA Lead, Sterilization & Microbiology

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); Vor Ort; USD 115.000 - 140.000; Vollzeit

Zusammenfassung

B. Braun Medical Inc. in Irvine, California is seeking a Senior QA Specialist – Sterilization to provide quality and technical expertise for sterilization and related microbiology activities across manufacturing and laboratory operations.

The role requires leading validation and revalidation efforts, developing strategies, and ensuring FDA/ISO/CMDR compliance while partnering with internal teams and external vendors. Travel may be required.

Qualifikationen

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

Aufgaben

• Provide quality oversight and guidance for sterilization activities to maintain product and process compliance.
• Lead validation/revalidation of sterilization equipment, methods and products.
• Develop validation strategies, manage schedules, and author, review and approve protocols and reports.
• Resolve complex sterilization and microbiology issues with scientific and quality judgment.
• Ensure compliance with FDA regulations, ISO standards and CMDR where applicable.
• Collaborate with internal teams and external contractors/vendors; train junior staff.

Kenntnisse

Technical writing

Problem solving

Communication

Cross-functional collaboration

Independent work

Travel

Ausbildung

Bachelor’s degree in microbiology or related

Master’s degree preferred

Jobbeschreibung

B. Braun Medical Inc. in Irvine, California is seeking a Senior QA Specialist – Sterilization to provide quality and technical expertise for sterilization and related microbiology activities across manufacturing and laboratory operations.

The role requires leading validation and revalidation efforts, developing strategies, and ensuring FDA/ISO/CMDR compliance while partnering with internal teams and external vendors. Travel may be required.