Job Description
- Job Title: Scientist 2 – Physical Testing
- Contract: 12 months
- Location: Deeside
- Pay – 35k
SRG is partnered with a global medical products and technologies company. Our client focuses on solutions for managing 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:
- Work within a controlled ISO13485 and ISO9001 Laboratory quality system, following GLP/GMP procedures.
- Design, plan, and execute physical testing supporting New Product Development activities in accordance with procedures and guidelines.
- Develop and validate new Physical Testing Methods.
- Author validation protocols, reports, and technical documents for medical devices/pharmaceutical products.
- Organize workload effectively; ensure data integrity and timely, accurate results in line with GLP standards.
- Record and analyze laboratory data accurately, adhering to good documentation practices.
- Conduct detailed laboratory investigations to determine root causes of atypical and out-of-specification results; implement corrective and preventative actions; write investigation reports.
- Assist in revising laboratory test methods and procedures.
- Manage standard laboratory routines, equipment calibration, maintenance, and replenishment.
- Ensure laboratory compliance with cGMP regulations and SOPs/TDs.
- Participate in change control activities and related actions.
Education/Qualifications:
- Bachelor’s Degree in a relevant science-related discipline.
- Approximately 2 years’ experience in a laboratory environment within the Medical Devices or Pharmaceutical industry.
- Knowledge of compliance with FDA and European regulations related to Quality Systems (ISO13485:2016, ISO9001:2015, FDA 21 CFR part 820).
- Broad understanding of physical testing.
- Strong analytical and problem-solving skills.
- Good interpersonal skills and team-oriented attitude.
- Proficient in Microsoft Office, especially Word and Excel.
- Experience in method development and validation is desirable.
- Knowledge of statistical analysis and familiarity with Minitab is advantageous.
Competencies:
- Understanding of the role of Physical Testing in product development for medical devices/pharmaceuticals.
- Good physical testing and problem-solving skills, with knowledge of initiating and completing testing tasks supporting R&D projects.
- Ability to analyze data statistically for reporting purposes.
- Effective oral and written communication skills for scientific and technical data.
- Understanding of compliance management, GMP/GLP, and documentation practices.
- Capability to produce high-quality, accurate R&D documentation promptly.
- Team player willing to accept new challenges and work under tight deadlines.
- Flexible, able to prioritize, manage multiple tasks, and adapt to changes.
- Detail-oriented with high accuracy.
- Decisive, able to make independent decisions and recommendations.