OOS Exception Specialist

As OOS / Exception Specialist you are supporting our QC Analysts with the follow-up of deviation results of their performed assay in the QC 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.

Additional Information :

Eurofins BioPharma Product Testing Leiden B.V.: A world of possibilities   

This position is based at Eurofins BioPharma Product Testing Leiden on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins BioPharma Product Testing Leiden also offers:    

• A competitivesalary;   
• Flexible working hours;   
• 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract);   
• Travel allowance of 23 cents net per kilometer. Are you traveling by public transport Then your travel expenses will be fully reimbursed via NS Business Card;   
• Participation in a pension scheme with 50% contribution by Eurofins;   
• Each month you accumulate a choice budget balance of 8.5% of your gross salary. This includes among other things holiday pay and a year-end bonus. You can choose to have this amount paid out or you can use it to buy extra days off for example. You choose what suits you best;   
• Discount on additional health insurance;   
• Tax benefit via FiscFree when purchasing various products and services via your gross salary such as a bicycle sports contribution fitness mobile telephony computers & tablets or a weekend away;   
• Professional training and opportunities for training and development;   
• Training options via the online learning platform Good Habitz.   

Working at Eurofins BioPharma Product Testing Leiden offers you the flexibility and personal touch of working in a medium sized and dynamic company whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:   

• Diverse developmental opportunities within the organization;   
• A large client portfolio ensures a lot of diversity in your work.   

More about Eurofins Scientific  

Eurofins Scientificis an international life sciences company providing a unique range of analytical testing services to clients across multiple industries to make life and our environment safer healthier and more sustainable. From the food you eat to the water you drink to the medicines you rely on Eurofins works with the biggest companies in the world to ensure the products they supply are safe their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food environmental pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics discovery pharmacology forensics CDMO advanced material sciences and in the support of clinical studies. 
 
In over just 30 years Eurofins has grown from one laboratory in NantesFrance to over 62000 staff across a network of more than 1000 independent companies in over 62 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200000 analytical methods to evaluate the safety identity composition authenticity origin traceability and purity of biological substances and products as well as providing innovative clinical diagnostic testing services as one of the leading global emerging players in specialised clinical diagnostics testing. 
 
In 2025 Eurofins generated total revenues of EUR  7.296 billion and has been among the best performing stocks in Europe over the past 20 years. 

Would you like to know more  

For questions regarding the position please follow the link below Im interested in order to contact the hiring manager.  

Acquisition for this vacancy is not appreciated. 

Remote Work :

No

Employment Type :

Full-time