Senior Quality Assurance Specialist
vor 1 Monat
Join Lonza's Team of Experts
Senior QA Specialist (Hybrid) - Contamination Prevention & Control
Location: Global Leader in Life Sciences
Hybrid Working Model (3 days in the office, 2 days WFH)
At Lonza, we're a global leader in life sciences, operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.
The Role:
We're looking for a Senior QA Specialist, Microbiological Quality Assurance and Contamination Control, who will impact the quality of our manufacturing facilities, processes, and products. You'll collaborate virtually with all functions at the site, supporting end-to-end contamination control strategies within our site manufacturing and support units.
Key Responsibilities:
- Provide Quality oversight for the qualification (environmental monitoring PQ) of manufacturing facilities and PQ of clean utility systems.
- Ensure facility and quality systems are compliant with internal requirements and appropriate regulations, participating in developing action plans to correct deficiencies to ensure the adequate microbiological quality of the site facilities, utilities, processes, and products.
- Analyze and interpret environmental monitoring data, identify trends, and implement adequate 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 and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures. Provide microbiological expertise to support Investigations, CAPAs, and Change Control related to Contamination Prevention and Control.
- 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.
Key Requirements:
- Bachelor's degree in a relevant scientific discipline (preferably in microbiology).
- 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 microbiological control strategy required.
- Fluency in English, ability to communicate in or willing to learn German.
At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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