As OOS / Exception Specialist you are supporting our QC Analysts with the follow-up of deviation results of their performed assay in the QC laboratory. In this specialist role you work together with the involved Analyst, Lab Supervisor and QA to lead the investigation. You also communicate with clients regarding the Out of Specification or Exception for possible re-testing and exception reporting.
As OOS / Exception Specialist, you will be responsible for:
- Immediate troubleshooting after detection of unexpected testing results or any other irregularities in the primary testing process.
- Decision making to open an Exception - or OOS record in eLIMS, in agreement with department management and QA.
- Client notification and follow up communication (if required) in the case of a client specific OOS or critical Exception in agreement with QC review, QA and relevant client specific Quality Agreement.
- Leading the investigation in cooperation with the relevant stakeholders and clients (if needed) and apply root cause analysis tools.
- Propose (re)testing plans and gather approvals from QA and clients (if required).
- Proper technical writing and finalization of exceptions within due dates and in-line with expectations from QA policy, GMP guidelines and applicable regulations.
- Proposing and implementing CAPAs in cooperation and agreement with the responsible department and QA.
- Execute (re)training of involved staff as part of the OOS - or Exception investigation where needed.
Qualifications
We are looking for someone with experience in troubleshooting deviating lab results. The ideal candidate for the OOS / Exception Specialist has:
- Completed a BSc or MSc education in Biopharmaceutical Sciences, such as Chemistry, Biology or in a similar discipline.
- At least 3 year of work experience in deviation management.
- Working experience according to GMP (Good Manufacturing Practices) in the (bio) pharmaceutical industry.
- Good command of the English language orally and in writing is required. Dutch is considered a plus.
- Excellent communications and organizational skills to interact with clients and internal stakeholders.
- Flexible mindset in order to work effectively in a dynamic environment.
- A responsible, analytical and pro-active attitude to resolve the OOS and Exceptions in a tight timeframe.
- You are located in the Netherlands, or you are planning to relocate to the Netherlands and are in possession of a valid work permit.