Quality Analitycal Associate Microbiologist

Conteúdo do emprego

Description

The main responsibilities for the Quality Analytical Associate I Microbiology includes execution of all of the Microbiology related testing activities at a new large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include: microbiological identification, bacterial endotoxin test (kinetic-chromogenic), detection of microorganisms (BacT/Alert) and microbial enumeration test. Additional tests will include Total Organic Carbon and conductivity. Administrative activates part of the execution of Microbiology methods are part of the daily business including troubleshooting during testing and review activates, documentation and archival of data, as well as supporting the deviation management of the QC Microbiology team. In addition, the Quality Analytical Associate will contribute to the development and execution of QC Microbiology related supporting studies.

The Quality Analytical Associate I has a background in microbiological analytical methodologies and a strong quality mind set. The Associate I works according to Good Documentation Practices (GDP) and cGMP rules. Testing includes the use of computerized systems, the Associate I ensures data integrity during all activities. The Quality Analytical Associate I supports the Microbiology Team with establishing analytical procedures, protocols and reports related to microbiological analysis.

The Quality organization at the new 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.

Main Responsibilities

• 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 (eg 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.
• And other job duties that may be assigned from time to time.
  

Education Requirements

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

Minimum Experience Requirements

Experience within Biological Quality Control, Microbiology and analytical function. Experience in pharmaceutical or biotech manufacturing environment is a plus.

Skills

• Validation
• change control
• cGMP
• Process valid
• process validation
• process validation protocols
• Quality management
• Quality assurance
• Quality management system
• Root cause analysis
• Quality engineering
• Quality control
• SaMD
• medical device
• Document control
  

Job Title: Quality Analitycal Associate Microbiologist

Location: Solothurn District, Switzerland

Rate/Salary: .00 CHF Hourly

Job Type: Contract

Trading as Aerotek and Actalent Services. Allegis Group Limited, Bracknell, RG12 1RT, United Kingdom. No. . Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on our website.

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