QC Analyst I / Raw Material Specialist (2008086)

Description

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SWX Swiss Exchange. In 2007, Lonza had sales of CHF 2.87 billion. Further information can be found at www.lonza.com

To perform tests within the Quality Control Department in support of cGMP manufacturing.

Responsibilities:Execute assays with minimal supervision Read, understand and utilize SOPs within the Chemistry/Raw Materials Labs Follow the actions and rules of all compliance programs Demonstrate competence and consistency in assay data packet compilation Participate in investigations such as Assay Failure Reports and raw material investigations Demonstrate competency in instrumentation knowledge; knows how to use, clean and maintain equipment Recognize problems with equipment, assays or procedures and reports them to their Supervisor. Communicates possible solutions to resolve these issues Capable of solution and reagent preparation without supervision. Maintains these solutions availability in order to support the workload within the lab. May participate in assay transfer Perform In-Process sample testing, Environmental Monitoring, Stability testing, Raw materials inspection, sampling, and testing and Product Changeover Generate and revises SOP's as needed Maintain cGMP of the lab (QC Chemistry and Raw Materials Lab) and follow the actions and rules of all compliance programs (i.e. log book entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipments, QC daily laboratory maintenance log, etc. Order supplies for the lab in a timely manner to support the workload within the labs Play an active role in the preparation and maintenance of the labs for audits (FDA, EU, and Customer Based).

~cb~Required Skills



Experience should include: Raw Material inspections, sampling, testing, in-process support testing, aseptic technique in a GMP setting; Raw Materials, pH, Conductivity, identity testing, aseptic technique

Good understanding of cGMP's, good attention to detail, good interpersonal skills, team player

Computer skills in MS Word and EXCELRequired Experience

BS/BA in science and 1-2 years experience in a Quality Control laboratory performing microbiological or analytical assays ideally in a biotech or pharmaceutical environment Please apply on our website at: www.lonza.com