- Working within a controlled ISO 13485 and ISO 9001 Laboratory quality system and in accordance with GLP/GMP procedures.
- Design, plan and execute Physical testing in support of R&D activities and base business projects in accordance with applicable procedures and guidelines.
- Involvement in the development and validation of new physical testing methods.
- Effective organization 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.
- Author validation protocols, reports, and technical documents for medical Devices/ Pharmaceutical products
- Assist in laboratory test method/procedural revisions.
- Responsible for standard laboratory routines, equipment calibration, maintenance replenishment etc.
- Ensures lab compliance with applicable cGMP regulations and SOPs/TD's.
- Involvement in change control activities and associated actions.
- Perform basic statistical analysis of test data.
- Support laboratory admin activities , shipping samples, scanning, logging of samples etc.
- Support minor calibration activities
- Good written and verbal communication skills.
- Good working knowledge of Microsoft Office, specifically Word and Excel.
- Familiarity with safe working in a laboratory environment. 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 GMP Guidelines and Regulation.
- Understanding of common statistical analysis and experience with Minitab desirable
- Bachelor's Degree in a relevant science-related discipline, , biological sciences.
- Speaking: Yes English
- Writing/Reading: Yes English
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Research Assistant - Deeside, United Kingdom - ConvaTec
Description
Pioneering trusted medical solutions to improve the lives we touch: Unomedical is a member of Convatec which is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visitOur search for better is changing the lives of our customers. It's changing the careers of our people too –creating new challenges and opportunities all the time. We're a business that never stands still. Join us on our journey to #ForeverCaring as Research Assistant, and you won't either.
About the Role:
A Research Assistant in the Physical Testing Department supports the product development process for medical devices. Research Assistants should have a good understanding of the importance of physical testing in ensuring the safety, efficacy, and quality of medical devices. Research Assistants are responsible for conducting various tests and experiments to assess the physical properties of medical devices. Research Assistants will generate, document, and analyze data in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). Research Assistants should be detail-oriented, able to work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential.
Key Responsibilities:
About you:
Languages
Our ambitions will bring the very best out in you. You'll be pushed to aim higher and really own your work. You'll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it'll be worth it.
This is stepping up to a challenge.
This is work that'll move you.
#LI-CH2
#LI-Remote
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
