About the job R&D Documentation & Laboratory Assistant
Oystershell specializes in the innovation of consumer healthcare products and especially in over-the-counter products (OTC). Our mission is to bring to the world new health products that combine scientific progress with consumer insights to improve people’s lives and health. Oystershell develops these innovations for its two business units: sales to third party customers (Oystershell Laboratories) and sales from own brands in a selection of categories: head lice treatment, insect control and premium dietary supplements (Oystershell Consumer Health).
Oystershell is an innovative and creative growth company with international ambitions where we recognize talent in a positive work environment. Entrepreneurship, Creativity, Integrity & Collaboration characterize our culture. Working in Oystershell is achieving our goals as one team with dynamic and enthusiastic people!
As a R&D Documentation & Laboratory Assistant you support the R&D Management team for all our new and existing development projects.
The role of R&D Documentation & Laboratory Assistant is an integral part of the organization. You apply extensive organizational skills and knowledge as an individual and as part of a team to assure that documents meet the needs of the organization as well as the regulatory requirements (in terms of standards and regulations) and quality assurance requirements (in terms of good documentation practices).
You provide significant guidance as well as hands on support in the development of new documents, procedures and changes to existing procedures, processes, plans, and other quality system documentation. You support the creation of all R&D-documents required for dossier submission and/or updating documents under (Sr.) R&D Manager supervision.
You manage changes to any piece of R&D documentation: all documents must be stored and organized to facilitate efficient and timely retrieval via the documentation system.
You are responsible for maintenance of the laboratory stock of raw materials and consumables, samples request, upload of relevant documentation, and follow up with suppliers. You ensure a smooth working environment of the laboratory and make positive changes to the organization of the laboratory.
Required skills, educational and experience requirements
- Minimal bachelor’s degree in life science
- Preferably a couple of years of working experience
- Competency in using Microsoft Office (Excel, Word, PowerPoint, Teams, Outlook, MS Project)
- Experience with Document Control software (MasterControl) and ERP software (MS Dynamic NAV) is a plus
- You are fluent in the English language (speak, read, and write).
- You understand and comply with all quality procedures.
- Nice to have:
- Document Control experience (medical devices, biocides, cosmetics, general sales)
- Experience with working in a regulated environment (production, lab) - GMP
- Experience with working within ISO Quality Systems
Expected professional attitude
- You have a mature, positive personality and love challenges.
- You are able to work independently and you are self-motivated with a strong sense of urgency.
- You are efficient and well organized with the ability to effectively establish priorities and produce accurate work in a fast-paced environment with minimal supervision.
- You are detail-oriented with strong communication and writing skills.
- Above all, you are a team player. You are able to work in a team environment including both internal and external resources.
- It is our expectation that you live up to our quality standards as described in the quality policy. We expect you to take the necessary actions to comply with the quality objectives.