At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
Our vision: We strive to be the leading supplier using science and technology to improve the quality of life.
Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary Duties and Responsibilities: - To perform QC test as required.
- Supervising the review of laboratory data (both internal and external) and the closeout of deviations.
- Scheduling of testing - coordinated with the other departments delivering samples to ensure timely delivery of results.
- Supervision of all testing techniques
- Responsible for ensuring that all personnel involved in testing are trained in basic CGMP training and are getting routine updates in CGMP information and training
- Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and Sops
- Responsible for data and logbook review
- Customer and regulatory agency interaction as required
- Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance and documentation issues are resolved
- Evaluations of vendors via vendor audits, comprehensive testing and review of quality performance
- Perform report writing (Example: Deviations/Investigations/Trending)
- Involved in equipment qualification
- Perform annual performance evaluations of all direct reports
- Provide continued coaching and developing of subordinates to help them meet both their career and personal development goals and to ensure a cohesive, productive and highly motivated team
- Any other duties as assigned by your Manager
Education / Experience - Degree in a relevant Science field or Equivalent
- 6-8 years of relevant work experience, preferably lab experience in a biotech QC related field
- With min 3-5 years supervisor experience, demonstrate solid leadership skill and ability to lead a team
- Good understanding of principle of Chromatographic testing, especially familiar with various HPLC methods for protein sample testing
- Familiar with Empower software
- Experience of analytical method transfer and/or method validation is preferred
- Good report writing skill and able to lead/author investigation report independently
- Demonstrate troubleshooting and problem solving skills
- Demonstrate effective communication skill.
Lonza. The place to Go, Stay and Grow.
