Specialist ELISA - QC

As a Specialist ELISA - QC, you will play an important role within the team as the subject matter expert for ELISA. You will support QC analysts with questions related to ongoing ELISA methods and ensure that QC activities are carried out to a high standard in accordance with the applicable GMP and safety guidelines. The role is primarily focused on specialist support, investigations and improvement activities, with very limited hands-on laboratory work.

We are constantly striving to better organise and further improve our processes. To this end, we enthusiastically use various Lean/Six Sigma tools such as tiers, kaizens and root cause analysis. We are looking for an experienced Specialist ELISA - QC who is open to change, continuous improvement, self-critical and thinks in terms of solutions rather than problems.

Responsibilities:

• Knowledge of serological ELISA potency testing and being a subject matter expert is a requirement.
• Supporting QC analysts with questions related to ongoing ELISA methods, including facilitating regular ELISA support sessions.
• GMP knowledge is a requirement.
• Identifying, analysing, coordinating and reporting (OOS) deviations and trends, including necessary cross-functional laboratory investigations in accordance with applicable GMP procedures.
• Implementing and/or leading corrective and preventive actions and improvement initiatives arising from deviations, including CAPA and 8-step root cause investigations.
• Supporting and leading change controls related to ELISA methods and processes.
• Point of contact for the QC department with regard to deviations, changes, audits, training and documentation, such as system documents, SOPs and work instructions.
• Assessing QC test results.