quality analytical associate microbiology in Luterbach

Randstad Professionals is looking for a Quality Analytical Associate Microbiology for a major client based in Solothurn.

Contract period: 6 months

Start date: ASAP

The main responsibilities for the Quality Analytical Associate Microbiology includes execution of all of the Microbiology related testing activities at the clients new large scale manufacturing facility in Solothurn, Switzerland. 

• Accountable to support IQ / OQ / PQ of instrumentation and method validation in alignment with the standards (microbiological identification, bacterial endotoxin test, detection of microorganisms and microbial enumeration test)

• In addition, the Quality Analytical Associate will contribute to the development and execution of QC Microbiology related supporting studies. 

• Work in-progress (WIP) laboratories are embedded into, or adjacent to, the manufacturing workspace at the clients new facility. All operations at the facility are focused on batch production and release of the drug substance materials produced at the site. 

• The Quality Analytical Associate III has to support all activities to ensure that the instrumentation in these WIP labs is prepared for each corresponding unit operation to be performed in manufacturing. 

• Support of  training of the On-The Floor (OTF) Quality staff members and Manufacturing Associates that will perform routine test execution. While the OTF staff and Manufacturing Associates has accountability for routine test execution, trouble shooting of analytical or assay related issues is supported by the Quality Analytical Associate. 

• Analytical methods or techniques requiring segregation from the manufacturing areas will be maintained in a central laboratory adjacent to the manufacturing buildings. 

• Techniques to be performed in the central laboratory will include growth promotion test, microbial enumeration of in-process and EM/UM samples, Bacterial Endotoxin Test (kinetic-chromogenic) and microbiological identification. 

• Support the preparation of the Microbiology lab and WIP lab for routine operations and support the execution of analytical capability strategy 

• Work cross functionally to support purchasing, receipt, IQ/OQ/PQ of analytical equipment for the Solothurn site. 

• Perform all analytical activities for equipment qualification and validation of microbiological methods and subsequent routine operations 

• Support the environmental and utility monitoring program for the site. 

• Support day to day operations within the Central and WIP labs. 

• Author and review approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.)

If you are interested to take on these responsibilities you should have the following requirements:

• Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.

• Strong experience within Biological Quality Control, Microbiology and analytical function. Approximately 4 plus years of experience in pharmaceutical or biotech manufacturing environment.

• strong background in microbiological analytical methodologies.

• Strong 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 oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively 

• Ability to multi-task  with 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)

We can offer you a new challenge in a diverse, innovative and multicultural environment. Have we sparked your interest? Then we look forward to receiving your online application.

Please note a Swiss Work permit or EU-citizenship is mandatory for this position.