Associate Ii Quality Control Sample Management
vor 1 Woche
**Job Description** About This Role**
Your main responsibilities as Associate II Quality Control (QC) Sample Management & Logistics will include sample management related activities at Biogen’s manufacturing facility in Solothurn, Switzerland. You will be responsible for the management of QC test, stability & retain samples including GMP compliant documentation. The management means: The moving and shipping from site locations to internal and external locations with the main goal to ensure the chain of custody and according to standard work operations. Therefore, you will also need to work with a laboratory information management system (LIMS), as well with enterprise resource planning systems like Oracle. The work duties include the preparation of sample shipment documents in collaboration with trade compliance and warehouse department to ensure to be fully compliant according GMP but also legal requirements.
The manufacturing science (MS) department also generates samples but in another regulatory environment. It is also the responsibility of Associate II to manage the MS samples through TD LIMS. Other sample management duties are following the QC sample requirements. As manufacturing process provides drug substance sample bags, which need to be aliquoted and sub-sampled to different pack sizes, consumables, and lower volumes it is the responsibility of Associate II to perform aforementioned activities. This is a very critical operation in order to ensure all sample integrity.
The Associate II Quality Control will be responsible for the ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site inclusive WIP and Raw material areas. The Associate II needs to collaborate with the responsible persons of the related vendor managed inventory (VMI) system. It also includes the preparation of solutions like liquid chromatography buffers, TOC testing (solutions and consumables) or other analytical solutions. Furthermore, reference standards and qualified materials need to be ordered and managed for the quality control teams, whereby a close collaboration with the global reference QC group is mandatory. Associate II will be also responsible for washing and distribution of QC labware.
You will be responsible that all QC related non-analytical testing equipment like freezers are in a GMP-compliant status. The job duties include work order management, defrosting & cleaning activities.
The Biogen Solothurn campus operates with high-automated and integrated systems which also trigger GMP relevant alerts. The Associate II is responsible to assess and process those alerts via the quality review manager (QRM). You will work in a GMP compliant environment, where you will need to author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.).
**What You'll Do**
- Management (preparation, moving, shipping) of QC test, stability & retain samples including trade and GMP compliant documentation including support of day to day operations within the site.
- Aliquotation & sub-sampling of drug substance bags to QC samples.
- Sample Shipment: Organize and coordinate sample shipment for raw material tailgate samples, material science tailgates, manufacturing science samples, analytical development and technical development samples as well as shipment to partner organizations and CLOs.
- Support day to day operations within the Central and WIP laboratories, including management of work orders for QC related non-analytical testing equipment like freezers.
- Ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site, as well as management of QC labware.
- Authoring, reviewing and approving complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.).
**Who You Are**
**Qualifications**
- Associate’s Degree, technical degree (1-2 years), or Bachelor’s Degree.
- Prior experience in pharmaceutical or biotech manufacturing environments, preferably in GMP Quality Control.
- Basic knowledge of Microbiology and Chemistry.
- Skills in buffer and solution preparation are preferred.
- Experience in aseptical working.
- Strong organizational skills and ability to work autonomously.
- Effective communication skills across all levels of management, peers, contractors, and external partners.
- Proficiency in typical productivity software (Word, Excel, Outlook, etc.).
- Preferably familiar with LabWare LIMS and Oracle systems.
- Dual language proficiency preferred, with a preference for German and English (minimum level B1).
**Additional Information**
**Why Biogen?**
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact
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