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Senior Analyst, Raw Materials, Qc
2 weeks ago
Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three 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.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience - we, in Singapore are proud to be part of this global network.
As a Senior QC Analyst, you will support team leadership and drive results to meet department KPI's and able to make decisions independently.
**Key responsibilities**:
- To prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.
- Analysis of final product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods.
- Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).
- General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
- Support sample logistics area including retention sample storage, external lab test, QC documents control, shipment of QC samples.
- Prepare, maintain standards and reagents required by GMP documents.
- Responsible to follow data integrity requirements.
- Actively contributes to operational efficiency/continuous improvement initiatives.
- Problem solving of analytical methods as well as troubleshooting of equipment.
- Involved in equipment qualification, maintenance and troubleshooting.
- Support / Perform OOS, deviation investigations. Draft investigations reports.
- Be a trainer for test method.
- Involvement in method transfers and validation.
- Author Change Controls, Test Methods, SOPs.
- Lead Out -Of - Specifications (OOS) and deviation investigations.
- Supervising the review of laboratory data (both internal and external) and the closeout of deviations.
- Maintain knowledge of new technologies
- Strong ability to manage multiples priorities and lead projects.
- Customer and regulatory agency interaction as required.
- Involvement in method transfers and validation.
- Author Change Controls, Test Methods, SOPs.
- Any other duties as assigned by your manager.
**Key requirements**:
- Degree/Diploma in a relevant Chemistry, Science field or Equivalent.
- 5-8 years' work experience preferably with Lab experience in a biotech or medically related field.
- Good understanding of HPLC and Empower software.
- Understanding and execution of compendial monographs and the chemistry fundamentals behind methods. Technology/equipment may SDS-PAGE, UV, Infrared Spectroscopy, Nutrient analysis, Osmolality, HPLC, pH, Conductivity, Polarimetry, Refractometry, Density meter Titration (manual and automatic), as well as all compendial testing listed in the USP, JP and EP monographs.
- Provide support in HPLC equipment maintenance and qualification.
- Well versed in cGMP regulations.
- Good problem solving and analytical skills and a team player.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
- Reference: R58472
