Analyst Bioassay

Locatie: Leiden, Zuid-Holland, Nederland
Salaris: competitive
Sectoren: Quality Assurance
Soort functie: Freelance

Analyst Bioassay Team

The department
The Bioassay department is responsible for testing various samples ranging from early clinical up to commercial process control, release and stability using different methods and techniques e.g. ELISA, qPCR, Cell Culture.

The job
For our team, we are looking for an Analyst that will active handle the quality and compliance related issues, including medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls. To maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Expert (SME) during cGMP inspections and is New Product Introductions (NPI) contact person during the new product implementation process.

The key responsibilities of the jobholder:
1. Data analysis
The jobholder is responsible for deviation management within the Bioassay team. This includes, but is not limited to:
* Data gathering for assay performance, including raw data. Analyze the assay performance data to relate raw data to assay performance, propose and discuss improvement(s) for the assay(s) with different stakeholders (other sites, DPDS)
* Analyze and update capacity planning including calculated hours required for performance of the different assays.

2. Deviation Management
* 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.
* The job holder is 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.

3. Lab Execution
* The jobholder is responsible for ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe. This could be accomplished by means of the GAP analysis performed during the new product implementation.
* The jobholder server as Bioassay expert and will be requested to represent the team during internal/external meetings. The jobholder will act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses.
* The job holder is responsible for creating URS's in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
* Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines.
* Leads and drives continuous improvement processes.

- University/Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry.
- At least 2-4 years of relevant working experience in a (bio) pharmacy.
- Good technical writing skill in English Good knowledge of statistical data analyses Didactical skills in order to effectively transfer information in a training environment.

Are you interested? Please mail your updated CV to n.vanalfen[at] or call: 020 522 15 88.