OOS / Exception Specialist

2 weken geleden

Leiden, Nederland Eurofins Netherlands BioPharma Product Testing Voltijd
Job Description

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.

We are looking for an Analyst or OOS Specialist with experience in troubleshooting deviating lab results. 

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

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

PROXY and Eurofins: A world of possibilities

This position is based at Eurofins PROXY 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 PROXY also offers:

  • A competitive salary;
  • Flexible working hours;
  • 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract);
  • Travel allowance. Do you travel by public transport? Then your travel costs will be fully reimbursed;
  • Participation in a pension scheme with 50% contribution by Eurofins;
  • Each month, you accumulate a choice budget balance of 8.25% 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;
  • A cycling and/or fitness scheme to promote vitality;
  • Professional training and opportunities for training and development;
  • Training options via the online learning platform Good Habitz.

Working at Eurofins PROXY 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 Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, 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 for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2023, Eurofins generated 6.515 billion Euro proforma turnover in 900 laboratories across 62 countries, employing about 62.000 staff.

Would you like to know more?

For questions regarding the position, please follow the link below ‘I’m interested’ in order to contact the hiring manager.

Acquisition for this vacancy is not appreciated.

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