QA Systems Associate (0.5 FTE)

QA Systems Associate (0.5 FTE)

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The Quality Systems department is responsible for the development, maintenance, and evolution of the Quality Management System of Merus to ensure compliance with international regulations and support the achievement of quality objectives. As Quality Systems Associate you act as Business Administrator of Merus eQuality Management System. 

The Role:

In this position, you will be responsible for overseeing, supporting, and coordinating various aspects of the Quality Management System. Your key responsibilities will include: 
 
  • Act as Business Administrator and coordinate all aspects of the full operation of Merus eQMS including: 
  • Document Management 
  • Learning Management System (including study specific training) 
  • QMS (Change Control, Deviation handling, CAPA, Complaints, Supplier Management, Audit & Inspection) 
  • Manage GxP documents and ensure training is assigned appropriately  
  • Foster a quality mindset around Good Documentation Practices 
  • Collaborate with all GxP departments to provide customer service, analyze system incidents, and introduce system optimization 
  • Contribute to continuous development of Merus’ Quality Management System to address changing needs of Merus 
  • Compile, monitor and trend Merus quality indicators for weekly, monthly, and quarterly Quality Reviews 
  • Participate in and prepare for (internal) audits and inspections as SME. 
     
In addition, you will support in several other areas, such as inspection activities, contractor qualification audits and assessing changes/new developments in GXP regulatory in order to roll them out internally.  
 

Your Profile:


Your Profile 
We are looking for a highly organized and detail-oriented individual with experience with Document Management Systems. The ideal candidate will have a background in document control and quality management processes. It is a big plus if you have had any experience participating in audits and inspections. Effective communication skills, ability to collaborate and a proactive approach to continuous improvement are essential. 

Requirements:  
  • Degree in Biosciences or related field 
  • Minimum of 2-3 years relevant GMP work experience within biotechnology/ pharmaceutical /medical device industry, in a manufacturing or quality environment. 
  • Experience with MS Office (Word, Excel in particular) 
  • Proficient in an eDMS/LMS system, experience as business administrator is a plus. 
  • Knowledge of GMP; working knowledge of GCP, GDP 
  • Fluency in English (written and verbal) 

Why Merus?

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus and 30 days’ annual leave (based on a full-time position in the Netherlands). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.

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    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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    Merus is an equal employment opportunity employer that does not discriminate on the basis of actual or perceived race, color, religious creed, national origin, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, age, ancestry, disability or perceived disability, qualified handicap, gender identity, military status, veteran status, certain criminal records, genetic information or testing, HIV testing, or any other characteristic protected by applicable federal, state or local laws (each, a "Protected Characteristic"). We are dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

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