Quality Control Associate I Microbiology
Vor 5 Tagen
**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 endotoxin test (KCA and KTA), detection of microorganisms (BacT/Alert), growth promotion test and microbial enumeration test. In addition, the Quality Control Associate will contribute to the development and execution of QC Microbiology related supporting studies.
The Quality Control Associate I Microbiology must support all activities to ensure that the instrumentation in WIP labs is prepared for each corresponding unit operation to be performed in manufacturing.
The Quality Control Associate I Microbiology should have a background in microbiological analytical methodologies. The Associate must correctly work with cGMP regulated computerized systems which are necessary for the testing workflow as these systems will support the vision of establishing a paper-less lab and ensure the relevant data integrity. The Quality Control Associate I Microbiology supports the Microbiology Team with establishing analytical procedures and protocols related to microbiological analysis.
The Quality organization at the Solothurn site is envisioned to be supported by team members with diverse backgrounds that are capable of cross functional work to support the high throughput design of the facility. Quality staff is focused on incorporating a new operations strategy into the quality management systems, lab systems and business systems. The operational strategy strongly relies on the incorporation of online real-time monitoring, automation of routine testing wherever possible and integrated information technology systems to bring transparency to routine business operations.
**What You'll Do**
- Support the QC Microbiology team with day-to-day analytical operations including test execution and review activities of routine EM and UM samples, as well as MFG support samples (e.g. Cleaning samples) and in-process and drug-substance samples.
- Support administrative activities including archival of data, protocol/report and procedure drafting, analytical instrument maintenance activities, deviation management.
**Who You Are**
**Qualifications**
- Experience within Biological Quality Control, Microbiology and analytical function. Experience in pharmaceutical or biotech manufacturing environment is a plus.
- Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.
- Analytical skills in Microbiology.
- Must have a working understanding of modern analytical microbiological modalities to facilitate the execution of analytical quality strategies.
- Demonstrated problem solving skills.
- Demonstrated ability to work autonomously and cross-functionally.
- Strong presentation and organizational skills.
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.).
- Must have proficiencies with the Quality systems and business processes associated with Microbiology testing.
- 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 on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
-
Quality Control Associate I Microbiology
vor 1 Woche
Luterbach, Solothurn, Schweiz Biogen VollzeitJob 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 endotoxin...
-
Quality Control Associate Ii Microbiology
Vor 6 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
vor 2 Monaten
Luterbach, Schweiz Manpower VollzeitThe Associate II Quality Control is primarily responsible for managing various aspects of sample handling and documentation within the Quality Control department. This includes sample management, shipment coordination, ordering and distribution of reagents and consumables, equipment management, and authoring and reviewing GMP...
-
Quality Control Associate
vor 4 Wochen
Luterbach, Schweiz Manpower VollzeitThe Associate II Quality Control is primarily responsible for managing various aspects of sample handling and documentation within the Quality Control department. This includes sample management, shipment coordination, ordering and distribution of reagents and consumables, equipment management, and authoring and reviewing GMP...
-
Sr. Associate I, Quality Technical Services
vor 2 Wochen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About This Role** The main responsibility of the Sr. Associate I, Quality Technical Services & Compliance (QTS) is to serve as site liaison to global functions for documentation, training and corporate quality systems e.g. change control, CAPA, quality risk management, data integrity and exception management. The Sr. Associate I will...
-
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...
-
Associate Ii Quality Control Sample Management
vor 1 Woche
Luterbach, Solothurn, Schweiz Biogen VollzeitJob 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...
-
Associate Ii, Integrated Downstream Quality
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About This Role** The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment....
-
Associate Ii, Integrated Downstream Quality
vor 2 Wochen
Luterbach, Solothurn, Schweiz Biogen VollzeitJob Description About This Role**The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The...
-
Luterbach, Solothurn, Schweiz Biogen VollzeitAbout This Role The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn site is...
-
Luterbach, Schweiz Biogen VollzeitAbout This Role The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn...
-
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The...
-
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The...
-
Luterbach, Schweiz Biogen VollzeitAbout This Role The Associate II within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn...
-
QA Sr. Associate Ii
vor 2 Wochen
Luterbach, Schweiz Biogen Vollzeit**Job Description** A** **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...
-
Manufacturing Associate V
vor 3 Wochen
Luterbach, Schweiz Biogen Vollzeit**Company Description** 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...
-
Manufacturing Associate Iii
vor 3 Wochen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About This Role** As a Senior Manufacturing Associate III, 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...
-
Manufacturing Associate Ii
Vor 5 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description** 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...
-
Manufacturing Associate Iii
vor 2 Wochen
Luterbach, Schweiz Biogen VollzeitAs 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. If you thrive in a...
-
Manufacturing Associate Iii
Vor 5 Tagen
Luterbach, Schweiz Biogen VollzeitAs a Manufacturing Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream or downstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards. If you thrive in...
