GMP Scientific Data Reviewer - Gene Therapy
Eurofins
- Dungarvan, Co Waterford
- Permanent
- Full-time
- At Eurofins we offer careers not just jobs.
- Developmental opportunities and career progression
- Private Medical Insurance when with the company for 2 years for all roles
- Income protection and life assurance
- Free parking onsite
- Additional annual leave days with continued service
- The opportunity to work on life saving products
- Work-life balance
- Sports and Social events
- Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.
- Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.
- Data Reviewers are permitted to sign all technical documents within the company once their training in this task is successfully completed. This includes laboratory reports, SOPs, protocols, investigation reports and any other documentation issued.
- This person will perform analytical testing when not engaged in Data Review activities.
- This person will ensure that all documentation is completed on time, accurately and legibly.
- Responsible for updating any relevant documentation as required.
- Responsible for handling any customer related queries where necessary and liaising with their team to problem solve these queries if needed.
- To keep their training records up to date and to initiate training as per their training plan where possible when free from work
- To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
- To ensure that customers' requirements are fully met and in so doing be flexible to work in any area of the business as is required.
- To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement
- Degree in Molecular Cell Biology/Immunology or relevant Scientific discipline
- 3+ years' experience in GMP Pharma Laboratory
- Bio-assay, cell and molecular biology experience required
- Method validation and Data review experience.
- Experience with HPLC, LC-MS and/or viral vectors an advantage
- Good team player, organised, accurate and strong documentation skills.
- Strong attention to detail
- Passionate about quality and customer service
- Good communication skills both internally and externally