What will your job be
As Specialist QC Bioassays you are responsible for ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe. You also:
- jobholder serves as an expert on BioAssay technologies and will be requested to represent the team during internal/external meetings
- act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses.
- is responsible for creating URS’s in collaboration with automation specialist and provides lab input for the new equipment or technologies to NPI Lead.
- participates in or leads special projects or studies and will support short- and long-term projects meeting due dates within the established timelines.
- leads and drives continuous improvement processes
You will also be responsible for deviation management within the COVID-19 Vaccine Test Team, this includes:
- Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions
- Supporting and advising other lead investigators from external and internal QC departments
- Being responsible for the proper lab investigation and CRA’s for the medium/high-level Quality issues
- Monitor timely closure of medium/high-level investigations and associated CRA’s
What are we looking for
For the position as Specialist QC Bioassays we are looking for a candidate with at least 2-4 years of pharmaceutical experience, further more you have:
- A relevant BSc or MSc degree towards biosciences, pharmacy, (analytical) chemistry etc
- Good technical writing skill in English
- Good knowledge of statistical data analyse
- Effective skills to transfer information in a training environment
What do we offer
- Long term position, which starts with a 12 months contract at CheckMark
- Salary indication from €3078 gross per month based on a full-time position
- Full-time position,
Where will you work
Our client in the region of Leiden is a pharmaceutical company
specialised in the production of vaccines. The Vaccine Test Team is responsible for the execution of all analytical test methods using, amongst others, various BioAssay techniques.