Scientist 2 - Physical Testing
- Connah's Quay, Flintshire Cheshire
- Temporary
- Full-time
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- Job Title: Scientist 2 - Physical Testing
- Contract: 12 months
- Location: Deeside
- Working within a controlled ISO13485 and ISO9001 Laboratory quality system and in accordance with GLP/GMP procedures.
- Design, plan and execute physical testing in support of New Product Development activities in accordance with applicable procedures and guidelines.
- Development and Validation of new Physical Testing Methods.
- Author validation protocols, reports and technical documents for medical devices / pharmaceutical products.
- Effective organisation of assigned workload; ensures integrity of all data generated and timely/accurate provision of results to GLP standards.
- Accurate recording and analysis of laboratory data in accordance with good documentation practices.
- Perform detailed laboratory investigations to determine the root cause of atypical and out of specification results, apply corrective and preventative actions and author concise investigation reports.
- Assist in laboratory test method/procedural revisions.
- Responsible for standard laboratory routines, equipment calibration, maintenance replenishment etc.
- Ensures lab compliances with applicable cGMP regulations and SOPs/TD's
- Involvement in change control activities and associated actions.
- Bachelor's Degree in a relevant science related discipline
- 2 years' experience in a working laboratory environment, within Medical Devices / Pharmaceutical industry is preferred.
- Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and G
- Critical and analytical thinking and the ability to problem solve.
- Strong interpersonal skills and a good team player.
- Good working knowledge of Microsoft Office, specifically Word and Excel.
- Method development and validation experience is desirable.
- A detailed understanding of common statistical analysis and experience with Minitab desirable.
- Have an understanding of the role of Physical Testing within the product development process for both new product development and existing product development of medical devices / pharmaceuticals.
- Commands good physical testing and problem-solving skills and demonstrates an understanding of the steps involved in initiating and completing a variety of physical testing tasks to support key R&D projects.
- Statistically analyse data for reporting to senior physical testing staff
- Effectively communicate both oral and written scientific and technical data to peers and managers.
- A thorough knowledge and understanding of the principles and concepts of compliance management, GMP/GLP and good documentation practices.
- Competent in the production of high quality, accurate R&D technical documentation in a timely manner.
- A forward-thinking team-player who willingly accepts new challenges and works to tight deadlines.
- Commands Flexibility - ability to prioritise, manage multiple tasks and react/respond positively to changes in priority and workload.
- Accurate with excellent attention to detail.
- Decisive thinker: ability to make decisions and recommendations using own initiative.