Microbiology Support Scientist - IVD - GMP - Kent- £21k-£27k - Contract

Due to new regulations associated with the IVD market being put in place next year, our client is seeking 2 Microbiology Support Scientists to join them on long-term contracts. The contract will be 12-18 months long. Your role will be to support the Technical Process Development group to compile reports for Technical Files, Risk Management Files or Validation Studies although there will be the opportunity to carry out some bench work. It is essential you have a background in microbiology and have gained prior microbiology experience in a commercial environment. Knowledge of IVD's and surrounding compliance would be advantageous. 

With an audit scheduled for February 2017, they are seeking candidates that can start with them ASAP. 

The Role:

To work as a member of the Technical Process Development (TPD) group to compile reports for Technical Files, Risk Management Files or Validation Studies. This may involve conducting studies / investigations to gather data. Investigations could be targeted at process improvements, validation (products and methods), troubleshooting support for existing products and technical support for OEM opportunities. 

Key Responsibilities:

* Prepare or assist in the preparation of technical documentation to support compliance activities. This includes Product Specifications, Technical Data summaries, Validation Plans and Validation Reports. 
* To organise, plan and perform scientific investigations as part of a product, material or method validation process.
* To conduct technical investigation as directed by line management to produce a report, process improvement, support a change or solve a technical manufacturing problem. 
* Document clearly, concisely and securely all aims, materials, methods, results and conclusions of scientific investigations. Report results and observations to the line manager. Communicate such findings through discussions, meetings, monthly reports and other reports as required. 
* Prepare or assist in the preparation of product documentation. 
* Assist in calibration of equipment as appropriate.

Experience Required:

* BSc (Hons) in Microbiology or bioscience subject. Equivalent experience will be considered.
* Microbiology testing experience within a commercial laboratory, ideally in a pharmaceutical, biotech, medical device or food testing organisation
* Prior documentation or regulatory affairs knowledge would be advantageous but is not essential 
* Knowledge of GMP
* Knowledge of ISO 13485 regulations is preferred but not essential 
* Knowledge or experience of working with IVD's is highly desirable
 

• Contact: Katie Pink
• Reference: Totaljobs/BBBH4490
• Job ID: 67026411