Senior QC Lab Equipment and Quality Record Specialist 80-100
Vor 2 Tagen
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. 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. And that's the kind of work we want to be part of.
The actual location of this job is in Basel Stücki, Switzerland.
Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Senior QC Lab Equipment & Quality Record Specialist in QC Bio-Analytics.
We are looking for an agile person to join our Bio-Analytics support team. Your main responsibility will be quality records (Deviations / Investigations) in the Bio-Analytics unit. You will also be responsible for Bio-Analytics equipment (e.g. cooling devices, plate readers, SPR systems), their qualification in collaboration with our lab systems department, as well as quality records related to these equipment. Further tasks will include contribution to the set-up of a new LIMS system and the maintenance of our document training system. All activities are performed according to Good Manufacturing Practice (GMP) standards.
What you'll get:
- An agile career and a dynamic work culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
What you'll do:
- Participate in deviation / investigation / CAPA writing for the QC Bio-Analytics department
- Maintain the training records and assignments within our global training management system for the QC Bio-Analytics department
- Support the qualification/validation of analytical equipment in QC Bio-Analytics laboratories
- Review and approve qualification/validation related reports as required following cGxP
- Maintain equipment in QC Bio-Analytics laboratories in alignment with relevant SOPs
- Act as subject matter expert for dedicated laboratory equipment within audits and inspections
- Collaborate with cross functional teams and stakeholders
What we're looking for:
- Degree in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Engineering or similar field or on the job training as an Analytical Lab Technician
- Excellent understanding of GxP/quality and relevant regulatory requirements
- Experience in analytical equipment qualification/ownership
- Experience in Biacore / SPR systems is a plus
- Knowledge of quality management systems (e.g. TrackWise) and training management systems (e.g. Cornerstone) is a plus
- Good communication and inter-personal skills. Ability to work in a highly dynamic environment
- Good knowledge of English (written and spoken), German is a plus
At Lonza, our people are our greatest strength. Spread across 30+ sites and five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity shape what we achieve and how we achieve it. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
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