Quality Control Associate II Microbiology

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 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 II 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 Analytical Associate II Microbiology should have a background in microbiological analytical methodologies. The Quality Analytical Associate is expected to become a technical expert/SME for classical and rapid methods and its instrumentation. The Associate has to 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 Analytical Associate will support 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 will be 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 Quality Control 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.
• Author and review of GMP documentation (protocols, procedures, CAPAs, deviations, etc.).
• Maintain housekeeping and equipment maintenance including organization, cleanliness, and logbooks,
• Perform timely response to Out of Limit (OOA, OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrent are considered implemented.
• Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA++ principles.
• Perform GEMBA walk-throughs of laboratory areas to maintain compliance,
• Participate in health authorities’ inspections, internal and customer audits.
• Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA++ principles.

Who You Are

The ideal candidate has a background in microbiological analytical methodologies, works with cGMP-regulated computerized systems, and aims to establish a paperless lab. The role involves becoming a technical expert for classical and rapid methods, supporting the Microbiology Team, and participating in cross-functional activities.

Required Skills

• Experience within Biological Quality Control, Microbiology and analytical function.  At least 2 years of experience of experience in pharmaceutical or biotech manufacturing environment.
• Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.
• Analytical skills in Microbiology (Bioburden and endotoxin testing, Growth promotion test, etc…).
• 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 (drug substance).
• English (minimum level B1).

 

Job Level: Entry Level