Quality Assurance Associate - Microbiology

Solothurn  ‐ Vor Ort
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Beschreibung

Quality Control Associate I Microbiology

Location: Solothurn, Switzerland

Duration: 8 months

Responsibilities:

The main responsibilities for the Quality Analytical Associate I Microbiology includes execution of all of the Microbiology related testing activities at the Client's 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 activities part of the execution of Microbiology methods are part of the daily business including troubleshooting during testing and review activities, 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.

Required Skills:
  • 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 English oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
  • Ability to multi-task
  • 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)


Required Education:

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

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
08/2022
Von
Real Staffing
Eingestellt
29.07.2022
Projekt-ID:
2435388
Vertragsart
Freiberuflich
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