Senior Quality Assurance Specialist

vor 4 Wochen

Visp, Schweiz Lonza Vollzeit

Join Lonza's Team as a Senior QA Specialist

Location: Visp, Switzerland

Hybrid Work Model: 3 days in the office, 2 days WFH

Lonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise innovative solutions that improve lives worldwide. In exchange, we empower our employees to own their careers, develop new ideas, and make a meaningful difference.

The Role:

We are seeking a Senior QA Specialist to join our team in Visp, Switzerland. As a key member of our quality assurance team, you will play a critical role in ensuring the quality of our manufacturing facilities, processes, and products. You will collaborate with cross-functional teams to develop and implement contamination control strategies, ensuring the microbiological quality of our site facilities, utilities, processes, and products.

Key Responsibilities:

  • Provide quality oversight for the qualification of manufacturing facilities and clean utilities systems
  • Ensure facility and quality systems are compliant with internal requirements and regulations, and develop action plans to correct deficiencies
  • Analyze and interpret environmental monitoring data, identify trends, and implement corrective actions
  • Collaborate with cross-functional teams to ensure microbial contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes
  • Lead investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures
  • Develop and deliver training programs to facility staff on contamination prevention and control, cleanroom behavior, and hygiene best practices
  • Support regulatory inspections and customer audits as a pharmaceutical microbiology subject matter expert

Experience and Skills Required:

  • Bachelor's degree in a relevant scientific discipline (preferably in microbiology)
  • Substantial GMP experience in the biologics industry, with direct QA or directly relevant QC microbiology experience
  • Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA)
  • Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbial control strategy required
  • Fluency in English, ability to communicate in or willing to learn German

Lonza is committed to respecting and protecting our people and our environment. We strive to achieve our business results ethically and with integrity. If you are passionate about improving lives and making a meaningful difference, join our team as a Senior QA Specialist.

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