QC Microbiology Associate

Solothurn  ‐ Vor Ort
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Beschreibung

QC MICROBIOLOGY ASSOCIATE

Duration: min. 7 months

Location: Solothurn, Switzerland

Summary:

The main responsibilities for the QC Microbiology Associate Microbiology includes execution of all of the Microbiology related testing activities at the company'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 QC Microbiology Associate will contribute to the development and execution of QC Microbiology related supporting studies.

The QC Microbiology Associate 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 ensures data integrity during all activities. The QC Microbiology Associate 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 (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.
  • And other job duties that may be assigned from time to time.


Knowledge & 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)


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. (Lab experience; with routine QC Microbiology experience or QC Chemistry.)
  • Experience in pharmaceutical or biotech manufacturing environment is a plus.


Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
10/2022
Von
Real Staffing
Eingestellt
16.09.2022
Projekt-ID:
2463621
Vertragsart
Freiberuflich
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