OMPS/QC Engineer

The OMPS/QC Engineer supports QC operations for QC method transfer activities from development to QC Operations. He/she also provides support to set up and maintain the QC infrastructure, processes, procedures and methods (incoming materials, semi-finished product and finished product).

The OMPS/QC Engineer also supports event investigations (e.g. NCR/CAPA) and improvement actions related to assay or manufacturing performance and contributes to root cause analysis (RCA) of event investigations and implementation of related corrective and preventive actions.

Accountabilities

Accountabilities include, but are not limited to:

• Prepare and write accurate and reliable technical reports and records.

• Report and investigate lab and incoming inspection non-conformities conform the SOPs.

• Review lab journals/reports of colleagues and provide an expert opinion.

• Perform QC lab investigations for Out of Specification (OOS) results, trend analysis and make recommendations for issue resolution, including both corrective and preventive actions, and ensure appropriate implementation in collaboration with the corresponding process owner.

• Perform receiving inspection of incoming materials on time conform the applicable instructions, including release in ERP.

• Provide support to set up and maintain the QC processes (e.g. SLIMS, stability, Incoming inspection - SIM).

• Support in determining the methodology and way of implementing the experiments in a routine lab environment.

• Plan QC analysis for method validation and transfer conform the GMP guidelines and applicable instructions.

• Follow policies, SOPs and applicable guidelines concerning safety, quality, working conditions and environment.

• Evaluate QMS processes and provide feedback to colleagues for continuous improvement.

• Analyze events, Root Cause Analysis (RCA), develop and verify solutions following appropriate scientific methodology and a structured approach.

• Document findings, conclusions and recommendations conform Biocartis processes and in line with quality regulations.

• Arrange for suitable knowledge transfer as needed.

Profile requirements

• Bachelor or Master in Sciences or equivalent by training/experience.
• Master with preferably 2 years of experience in Pharma, Biotech, Medical Devices and/or in the IVD industry in area of expertise
• Bachelor with preferably 4 years of experience in Pharma, Biotech, Medical Devices and/or in the IVD industry in area of expertise
• Experience with manufacturing process, validation and/or QC development activities in a GMP/GLP environment is an asset
• Industrialization experience (assay/technology transfer to manufacturing) is a strong asset
• Molecular biology knowledge is a strong asset
• Excellent technical writing and reporting skills
• Thorough understanding of the molecular/analytical/chemical technologies and control of lab equipment
• Applied knowledge of molecular biological techniques (qPCR) and terms.
• Team player
• Good time and resource management skills
• Strong problem analysis and problem solving skills and creative thinking
• Result driven
• Ability to work independently
• Scientific integrity
• Eagerness to learn/assimilate novel concepts
• Respect peers and their work/working environment
• Flexible and thrives in a fast-paced environment
• Eye for detail, precise
• Has notion of
• Supply chain processes
• Good laboratory practices
• Supplier processes
• Equipment qualification
• QC development and validation
• Product Release processes
• Quality Events
• Applied knowledge of MS Office (Word, Excel, PowerPoint and Outlook)
• Knowledge of following software and database applications is a plus:
• Spotfire
• Biorad
• LIMS database system
• Quality management system
• Experience with HSE and GMP/GDP regulations
• Advanced knowledge, orally and in writing of English and Dutch.

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated.

We offer you a market competitive compensation package which includes a Flexible Income Plan. We also pay attention to the Wellbeing of our Employees.