Associate Ii Quality Control Sample Management

vor 2 Wochen

Luterbach, Schweiz Biogen Vollzeit

**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

  • Quality Control Associate Ii Microbiology

    Vor 7 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description** About This Role** The main responsibilities for the Quality Control Associate II Microbiology includes execution of all the Microbiology related testing activities at Biogen’s large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include microbiological identification, bacterial...

  • Quality Control Associate I Microbiology

    Vor 6 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description** About This Role** The main responsibilities for the Quality Control Associate I Microbiology includes execution of all the Microbiology related testing activities at Biogen’s large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include microbiological identification, bacterial...

  • Quality Control Associate I Microbiology

    Gefunden in: beBee S CH - vor 4 Wochen

    Luterbach, Schweiz Biogen International GmbH Vollzeit

    About This Role The main responsibilities for the Quality Control Associate I Microbiology includes execution of all the Microbiology related testing activities at Biogen’s large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include microbiological identification, bacterial endotoxin test (KCA and...

  • Senior Associate II, QA Downstream

    Gefunden in: Talent CH C2 - Vor 7 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    Job DescriptionAbout This Role The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...

  • Senior Associate II, QA Downstream

    Gefunden in: Talent CH C2 - Vor 6 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    Job DescriptionAbout This Role The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...

  • Senior Associate II, QA Downstream

    Gefunden in: Talent CH C2 - Vor 6 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    About This Role   The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland. It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...

  • Manufacturing Associate II

    Gefunden in: beBee S CH - vor 4 Wochen

    Luterbach, Schweiz Biogen International GmbH Vollzeit

    About This Role  As a Senior Manufacturing Associate II, your primary role involves Perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The...

  • Manufacturing Associate II

    Gefunden in: beBee S CH - vor 3 Wochen

    Luterbach, Schweiz Biogen International GmbH Vollzeit

    About This Role  As a Senior Manufacturing Associate II, your primary role involves Perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The...

  • Senior Associate II, QA Downstream

    Gefunden in: Talent CH C2 - Vor 3 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    About This Role   The Senior Associate II QA is being part of the Quality Compliance and Technical services team. This role is mainly responsible on Facility, Utilities and Equipment (FUE) Qualification and Validation at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/she is also responsible for the Quality...

  • Senior Associate II, QA Downstream

    Gefunden in: Talent CH C2 - Vor 5 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    Job DescriptionAbout This Role The Senior Associate II QA  is being part of the Quality Compliance and Technical services team. This role is mainly responsible on Facility, Utilities and Equipment (FUE) Qualification and Validation at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/she is also responsible for the...

  • Sr. Engineer II, Automation Core Systems

    Gefunden in: beBee jobs CH - vor 2 Wochen

    Luterbach, Solothurn, Schweiz Biogen International GmbH Vollzeit

    About this roleAs Sr. Engineer II, Automation Core Systems, you will be responsible for providing engineering and technical leadership in support of Data Systems at the Solothurn site. Responsibilities include collaboration and building partnerships with site stakeholders and customers to ensure service levels and strategic direction align to the...

  • Sr. Engineer II, Automation Core Systems

    Gefunden in: Talent CH C2 - vor 2 Wochen

    Luterbach, Schweiz Biogen Vollzeit

    Job Description About this role As Sr. Engineer II, Automation Core Systems, you will be responsible for providing engineering and technical leadership in support of Data Systems at the Solothurn site. Responsibilities include collaboration and building partnerships with site stakeholders and customers to ensure service levels and strategic...

  • Sr. Engineer II, Automation Core Systems

    Gefunden in: Talent CH C2 - vor 2 Wochen

    Luterbach, Schweiz Biogen Vollzeit

    Job DescriptionAbout this roleAs Sr. Engineer II, Automation Core Systems, you will be responsible for providing engineering and technical leadership in support of Data Systems at the Solothurn site. Responsibilities include collaboration and building partnerships with site stakeholders and customers to ensure service levels and strategic direction align to...

  • Weigh & Dispense Associate Iii

    Vor 7 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** Join our innovative team as a Weigh & Dispense Associate III, playing a crucial role in daily operations in a cGMP environment. You will be responsible for executing Weigh & Dispense manufacturing operations, managing material flow, and ensuring compliance to cGMP standards. As a detail-oriented professional with a...

  • Manufacturing associate V

    Gefunden in: Talent CH C2 - vor 2 Wochen

    Luterbach, Schweiz Biogen Vollzeit

    About This Role As a Manufacturing associate V you'll perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is...

  • Sr. Engineer II, Automation Data Systems

    Gefunden in: Talent CH C2 - Vor 3 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    Job DescriptionAbout this roleAs Sr. Engineer II, Automation Data Systems, you will be responsible for providing engineering and technical leadership in support of Data Systems at the Solothurn site. Responsibilities include collaboration and building partnerships with site stakeholders and customers to ensure service levels and strategic direction align to...

  • Sr. Engineer II, Automation Data Systems

    Gefunden in: Talent CH C2 - Vor 3 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    Job Description About this role As Sr. Engineer II, Automation Data Systems, you will be responsible for providing engineering and technical leadership in support of Data Systems at the Solothurn site. Responsibilities include collaboration and building partnerships with site stakeholders and customers to ensure service levels and strategic...

  • Manufacturing Upstream Associate Iii

    Vor 6 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** As a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance...

  • Manufacturing Upstream Associate III

    Gefunden in: Talent CH C2 - vor 2 Wochen

    Luterbach, Schweiz Biogen Vollzeit

    Job Description As a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards....

  • Manufacturing Supervisor

    Vor 6 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** In this role, you will lead and oversee a team of Manufacturing Associates, coordinate shift tasks, and ensure a commitment to cGMP compliance and safety procedures. You will play a pivotal role in maintaining updated manufacturing documentation and serve as a system expert, leading technical issue resolution and...