Job Description
* Job Title: Scientist 2 – Physical Testing
* Contract: 12 months
* Location: Deeside
* Pay – 35k
SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.
We are seeking a Scientist 2 to join their Deeside team.
Duties and Responsibilities:
* 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.
Education/Qualifications:
* Bachelor’s Degree in a relevant science related discipline
* Approx. 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
* Broad Understanding of physical testing.
* 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.
Competencies:
* 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.