QC Associate Microbiology
Manufacturing areas, incoming materials and utility supplies and products are all released and approved for use based on QC test results as generated by the QC Associate. QC Associate is responsible for planning and execution of daily quality assays and control activities while ensuring compliance with all existing GMP and safety standards in the area of responsibility.
- Preform Growth promotion testing of incoming materials and in-process samples.
- Preform BacT method validation and sterility verification studies,
- Preform Water monitoring (including Endotoxin), Gram staining of microbial isolates and method verification, and soon to be in routine use is microbial identification using VITEK (MALDI-TOF).
- Identification of microbial isolates.
- Performance of microbiological assays.
- Performance of verification and validation activities.
- Documentation completion.
- General inventory of QC Microbiology materials.
- Writing or review of documentation (e.g. SOP’s, Quality Instructions, protocols…) related to quality control activities
- Ensure proper operations of laboratory equipment
- Be supportive for the performance of QC methods during the transfer of QC assays and stability testing
- Cross-departmental cooperation to ensure timely processing and reporting of results
- Responsible for reporting test results towards Team Leader QC
- Initiation of Quality Events as NC’s, CRF’s and OOS’s
- Backup of Senior QC associate
- Main activities contain the performance of QC assays, mandatory for intermediate testing and the release of Drug Product.
QC Associate will have the possibility to expand experience in several QC assays spread over several projects, which brings variation, and flexibility in the job.
- The position requires a very precise and responsible working attitude.
- Intermediate or higher vocational education in chemistry/biotechnology.
- Preferably experience with GMP and basic knowledge of incoming materials, EM, microbiological (gram stain, sterility) or analytical (RT-qPCR, FACS) techniques depending of the area of interest.
- Good communication skills in English.
- Accuracy, tidiness, self-organized, flexible, attention to detail.
- Team player.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.