OOS / Exception Specialist

This role is with Eurofins BioPharma Product Testing Leiden B.V., a GMP-certified contract laboratory serving the (bio)pharmaceutical industry. Based at the Leiden Bio Science Park, the lab provides microbiological, viral, chemical, and physical quality control testing for pharmaceutical raw materials, intermediates, and finished products, and develops and validates product-specific methods in close collaboration with clients.

You will join a professional team consisting of a mix of young and experienced people with different backgrounds and experiences.

Job Description

As OOS / Exception Specialist you are supporting 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 (OOS) 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 the relevant client-specific Quality Agreement.
• Leading the investigation in cooperation with the relevant stakeholders and clients (if needed) and applying 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 years 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 communication 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

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:

• 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, including 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.