Biotech Manufacturing Coordinator
1 day ago
Job Description
As a QA Specialist at Lonza, you will be responsible for overseeing manufacturing processes in a large-scale, multi-product, GMP biotech contract manufacturing facility.
- Support day-to-day QA activities in compliance with SOPs/policies.
- Ensure process awareness, identifying operational factors affecting the process.
- Review and approve SOPs, protocols, reports, and records.
- Troubleshoot issues, weighing all information to determine optimal solutions.
- Lead small projects and manage deliverables effectively.
- Build strong working relationships with internal and external customers.
- Plan and coordinate future activities with other departments.
- Develop into a qualified trainer in the area of expertise.
- Review batch records, raise deviations, and compile lot genealogy.
- Evaluate process events based on SOPs/policies.
- Support changeover activities and provide oversight for document changes.
- Detect non-compliance with cGMP/GDP, provide corrective guidance.
- Participate in walkdowns, audits, and provide feedback for improvement.
- Lead or participate in deviation investigations, change controls, and CAPA plans.
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