Quality Control Technician
In this role, you will be responsible to provide specific subject matter expertise to allow compliance and process improvement initiatives to be developed and implemented. Recommendations consistently result in advancement of improvement initiatives resulting in delivery of business benefits. You will function effectively as part of cross-functional teams to deliver business benefits.
As a QC Technician, you will actively support the quality systems in manufacturing and the laboratory, which are in compliance with corporate quality standards such as: Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP) applicable according to the EU GMP’s and US FDA, as well as Standard Operating Procedures (SOP’s).
Duties & responsibilities:
- Coordinates and participates in the day-to-day activities of the QC Laboratory and ensures the timely and accurate completion of testing and reporting of Biochemical results for components, excipients, raw materials, reference standards, stability samples, intermediates and finished pharmaceutical products.
- Ensures that the approved biochemical methods and specifications used in the testing and release of products and materials meets validation acceptance criteria and are in compliance with latest pharmaceutical standards and requirements of the manufacturing authorization.
- Reviews and approves laboratory results and performs trend analysis. Assures the timely completion and distribution of quarterly utility reports. Brings any out of specification or out-of-trend results to the attention of the Manager QC.
- Ensures timely completion of laboratory deviations, investigations and change control procedures.
- Provides QC support for activities that are arising from the technology transfer of new products/formulations and contract manufacturing projects.
- Acts as a site Biochemical expert and assists the Manager QC
- Is able to detect areas for improvement and make proposals to improve the Biochemical QC quality systems, process flows and/or working environment.
- Is able to assess and improve/ assays with a minimum of supervision.
- Trains other technicians in (new) Biochemical assays in order to increase technical skills and knowledge.
- MSc or HLO, in Biochemistry.
- Knowledge of cGMP and cGLP regulations.
- >2 - 3 years (MSc) or >8 years (HLO) in a cGMP environment preferably in the biopharmaceutical industry.
- Highly Computer literate.
- Good verbal and written communication skills.
- Good report writing skills.
- Excellent verbal and written skills in the Dutch and English language.
- A thorough knowledge and understanding of current biochemical methodologies and associated instrumentation.
- Has the ability to apply the theory to practical situations.
MedImmune is the worldwide biologics business for the AstraZeneca Group. The company has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland with facilities in Pennsylvania, California, Kentucky, the United Kingdom, and the Netherlands.
With two marketed products and an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health.
MedImmune Pharma B.V. is located since 1993 at Lagelandseweg 78 in Nijmegen. At our Nijmegen manufacturing facility, we produce vials with drugs for research and commercial purposes, meeting a range of needs from potential cancer cures to vaccinations for premature babies. The facility consists of production, labelling and packaging, quality control, quality assurance, materials management, facilities and a host of other areas. MedImmune is a part of AstraZeneca since July 2007.
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