Job Description
Job Title - Scientist 2 – Physical Testing
Location – Deeside
Contract Length – 12 months
Pay Rate – 30-35k (Depends on experience)
Education/Qualifications
* Bachelor’s Degree in a relevant science related discipline
* 1-2 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.
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.