Quality Assurance Specialist
3 weeks ago
At Lonza, we're committed to excellence in life sciences. As a Quality Assurance Specialist, you'll play a crucial role in ensuring the highest standards of quality in our biopharmaceutical manufacturing processes.
Key Responsibilities:
- Provide QA oversight to QC/DS laboratory services
- Review and approval of protocols and reports
- Provide QA oversight in deviation investigation, discrepancy reports, and CAPA implementation
- Participate actively in Root Cause Analysis to enable effective and timely closure of records
- Provide Quality Change Request oversight for Lab service changes
- Liaise with cross-functions, communicating information and updates in a timely manner
- Develop good working relationships with internal and external customers
- Participate in cross-functional walk-downs and provide feedback
- Lead and coordinate projects, managing deliverables effectively
- Develop skills to be a Qualified Trainer in your area of expertise
- Develop skills to front auditors as SME, supporting QA oversight
Key Requirements:
- Bachelor's degree with significant years of experience in Quality Assurance in the biopharmaceutical industry
- Familiarity with regulatory requirements and local codes and standards (e.g., FDA, EMA, and ICH Quality Guidelines)
- Fair knowledge and experience of the practical and theoretical requirements of quality management systems in a GMP facility
- Able to operate independently with minimal supervision for routine work within established policies and procedures, receiving detailed instructions on new projects and assignments
- Meticulous and systematic
- Team player, with a strong focus on safety, quality, and timelines
At Lonza, we're dedicated to making a positive impact on millions of people worldwide. Our products and services have a significant impact on people's lives, and we're committed to achieving our business results in an ethical and responsible manner.
As a Quality Assurance Specialist, you'll have the opportunity to work on complex problems and develop new ideas in life sciences. You'll be part of a global network recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms, and extensive experience.
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