Scientist II in the microbiology laboratory in the Global Testing Laboratories. Responsible for providing scientific and technical support to the development of new products. This includes method development, validation and testing. Ensures that all work performed in the microbiology lab conforms to internal procedures, reflects applicable regulations/guidelines and meets industry best practice.,

Working within a controlled ISO13485 laboratory quality system and in accordance with GLP/GMP compliant procedures.
Perform routine microbiological tests to support the development of new medical device products.
Development and validation of new microbiological assays.
Accurate recording and analysis of laboratory data in accordance with good documentation practices.
Writes validation protocols, reports and technical documents.
Writes laboratory test methods/procedural revisions.
To perform routine review of laboratory bench books/data, logbooks, equipment records; verifies/validates spreadsheets.
Training of staff in microbial techniques and procedures.
Responsible for standard laboratory routines, equipment calibration, maintenance, replenishment etc.
Preparation and maintenance of microbial stock cultures.
Ensure compliance with quality control and laboratory processes and procedures; write non-conformance and change control reports when required.
Perform detailed laboratory investigations to determine the root cause for atypical and out of specification results, apply corrective and preventive actions and concise report investigations.
Write COSHH and risk assessments for laboratory procedures.

An understanding of the role of microbiological testing within the product development process, particularly as it applies to the development of Medical Devices/Pharmaceuticals.
Good microbiological and problem-solving skills and demonstrates an understanding of the steps involved in initiating and completing a variety of microbiological tasks to support key R&D projects.
Ability to execute experiments in an accurate, effective and timely manner, reporting progress to senior microbiology staff.
Excellent oral and written communication skills.
Ability to use own initiative whilst working as part of a team.
Ability to handle multiple tasks simultaneously.
Demonstrates an ability to handle multiple tasks simultaneously.
Proactive and flexible in adapting to a changing environment and ability to balance multiple, competing priorities to meet objectives.
Highly motivated, possessing excellent personal attributes as well as being a flexible team member willing to take on a wide variety of tasks.
A practical, methodical, and flexible approach to working.
Ability to work effectively and communicate in cross-functional teams, building co-operative working relationships., Degree qualified, ideally in Microbiology, Biology or a similar related discipline.
3+ years of experience in a working microbiology laboratory environment, preferably within a Medical Device/Pharmaceutical Industry is desirable.
Knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, FDA 21 CFR part 820) and GMP Guidelines and Regulations is desirable.
Good working knowledge of Microsoft Office, particularly Word and Excel.
Laboratory/Office Environment
Working in a laboratory environment with exposure to biological agents, chemicals and reagents.

2 temporary Scientific jobs in Wrecsam, Wrecsam - Wrexham