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Quality Assurance Specialist
vor 2 Monaten
Transforming Human Health through Quality Excellence
Cytiva is at the forefront of providing innovative solutions to revolutionize human health. Our customers are pioneers in life-saving activities, from fundamental biological research to developing groundbreaking vaccines, medicines, and cell and gene therapies.
As a Quality Assurance Specialist at Cytiva, you will be part of a dynamic team that continuously improves itself and the organization. You will work on challenges that truly matter, collaborating with people who care for each other, our customers, and their patients. With a global presence across 40+ countries, Cytiva offers a platform for growth and skill development.
As part of the Biotechnology segment at Danaher, we bring together technical expertise and talent to develop the next generation of life-changing therapeutics.
Key Responsibilities:
- Complaints Management:
- Receive, analyze, document, and respond to customer complaints in a timely manner.
- Perform regular complaint trend analysis to inform operational reviews, Management Reviews, and Complaint Handling Unit (CHU) meetings.
- Nonconformity and CAPA Management:
- Manage Non-conformance and CAPA (internal and external) processes; ensure root cause analysis and implement robust action plans.
- Follow up and verify CAPAs to ensure no recurrence and facilitate timely closures.
- Internal Auditing:
- Monitor QA KPIs and Escalate Trends:
- Ensure continuous improvement activities such as PSPs, CAPAs are raised as countermeasures.
Requirements:
- Bachelor's degree in an engineering discipline (e.g., mechanical or chemical engineering).
- Minimum 2-3 years of experience in a Quality role, preferably in the Life Sciences industry.
- Good knowledge of using MS Office tools such as MS Excel for analytics and data management.
- Ability to communicate effectively in both German and English (written and spoken).
Desirable Skills:
- Knowledge and awareness of Quality Control methods and techniques in the manufacturing industry.
- Technical knowledge of systems/devices used in the biopharma field.
- ISO 9001 certification.
Benefits:
- Attractive salary.
- Numerous benefits, including company pension scheme and accident insurance.
- Development opportunities at Cytiva and within the Danaher Group.
- International corporate environment in a rapidly growing industry.