Job title
Analyst Quality Control Microbio | 2 shifts
Prothya Job grade 6
Reports to job title Teamleader QC
Purpose of the job
As a Quality Control Analyst, you will play a key role in performing routine analyses and complex testing related to quality control. You will also provide technical support and training to less experienced colleagues. All activities will be carried out in strict compliance with current GMP regulations, applicable safety standards, and internal procedures.
Your main mission is to ensure the reliability and timely delivery of results while ensuring they meet established quality requirements.
Accountabilities
1. Work Planning and Organization
In collaboration with the Coordinator, Team Leader, and Supervisor, you will review instructions, guidelines, and priorities. You will discuss the tasks to be completed to ensure optimal work organization and make the necessary preparations to maintain a clear and structured overview of activities.
Your responsibilities include:
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Organizing and prioritizing your tasks according to the established planning schedule.
2. Execution of Quality Control Analyses
You perform quality control analyses, including both physicochemical and microbiological testing, on a variety of production-related samples.
Your responsibilities include:
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Receiving samples in SAP and assigning them according to storage temperature requirements.
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Collecting water, steam, and compressed air samples.
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Preparing intermediate products in solution and generating aliquots for analysis.
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Performing routine microbiological analyses in accordance with approved procedures.
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Conducting an initial assessment of results by comparing them to established specifications and limits, and reporting any out-of-specification (OOS) or abnormal results to the Team Leader.
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Closely monitoring expiry dates of reagents, culture media, and consumables, as well as controlling and managing Kanban stock levels.
3. Technical Support and Knowledge Sharing
You provide technical support, information, and guidance within your department.
Through your extensive knowledge of analytical methods and manufacturing processes, you are able to assess the impact of deviations and abnormalities. You leverage this expertise to support your colleagues.
Your responsibilities include:
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Supporting internal and external audits by preparing documentation and contributing to laboratory inspections, periodic reviews, and procedure alignment activities.
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Providing technical guidance and support to team members when required.
4. GMP Documentation and Compliance
You ensure accurate and compliant documentation throughout the execution of your duties, in accordance with GMP requirements.
You are responsible for:
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Independently preparing, completing, and submitting all required documentation in compliance with applicable procedures.
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Maintaining laboratory logbooks accurately and in a timely manner to ensure full traceability of activities.
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Ensuring all records are complete, accurate, and audit-ready.
5. Quality, Safety, and Environmental Compliance
You are accountable for the quality and safety of all activities performed, ensuring strict compliance with applicable legislation and environmental, health, safety, and quality standards.
In this context, you commit to:
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Ensuring you possess the required qualifications and training to perform your tasks safely and effectively.
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Applying Safety, Health, and Environment (SHE) regulations, complying with legal requirements, and adhering to GMP guidelines while maintaining aseptic behavior at all times.
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Actively contributing to internal policies related to employee well-being and environmental protection.
6. Continuous Improvement
You share responsibility for continuous improvement within your work environment by identifying risks and actively participating in process optimization initiatives.
Your responsibilities include:
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Proactively evaluating working methods and identifying opportunities for continuous improvement, including procedural enhancements.
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Proposing improvements to departmental operations and ensuring appropriate follow-up.
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Systematically reporting incidents and actively participating in corrective and preventive actions (CAPAs) to avoid recurrence.
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Updating QC procedures and documentation (SOPs, sampling instructions, sampling procedures, etc.).
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Acting as a point of contact for improvements related to your own analytical techniques and areas of expertise.
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Participating in laboratory analysis-related projects.
Education, Experience, and Skills
Education
Bachelor’s degree in (Bio)Chemistry, (Micro)Biology, Industrial Pharmacy, Biotechnology, or equivalent relevant experience.
Experience
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Minimum 3 years of experience in a similar role within the pharmaceutical industry.
Skills
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Proficiency with the Microsoft Office suite; knowledge of SAP and MasterControl is an asset.
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Good command of technical English and good knowledge of either Dutch or French.
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Detail-oriented, quality-focused, and able to work independently.
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After an initial training and familiarization period, willing to work occasional weekends (maximum two shifts per month, with compensatory time off and additional compensation).
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Strong organizational skills with the ability to manage multiple priorities effectively.
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Excellent communication skills and confidence in contributing to team objectives.
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Punctual and reliable.
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Able to identify unsafe situations, document near misses, and implement appropriate corrective actions.
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Escalates quality deviations to the appropriate management level.
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Strong problem-solving skills and keen attention to detail.
Our Company
Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
We offer
Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.
We also offer an attractive holiday system exceeding the legal holidays.
Furthermore, we value mutual respect and diversity is our strength.
At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
Are you moving along? Then !
