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Quality assurance specialist - sterile manufacturing

Carlow
beBeeAssurance
Quality assurance specialist
Posted: 23 October
Offer description

Job Description

We are seeking a Quality Assurance Specialist to join our team in Limerick, Ireland. As a key member of our quality assurance team, you will play a crucial role in ensuring the highest standards of quality and compliance in our sterile manufacturing facility.


About the Role:

This 12-month contract opportunity will have you working on a state-of-the-art fill-finish facility and our company's first stand-alone vaccine and biologics plant outside the US.


Responsibilities:

* Perform routine testing with high-quality documentation to support manufacturing and batch release.
* Review microbiological test data from utilities and environmental monitoring samples.
* Manage assay aspects, including controls, standard stock control, and SOPs/forms updates.
* Support process simulations and work as part of a team.
* Maintain laboratory housekeeping standards and demonstrate awareness of safety for self and others.


Requirements

To be successful in this role, you will need:

* 1-2 years' experience in the pharmaceutical industry (microbiology), preferably in sterile manufacturing microbiology lab environment.
* Knowledge of cGMP and GDP.
* Laboratory Quality Systems proficiency.
* Proficiency in Microsoft Office and job-related computer applications.
* Understanding of Lean six Sigma Methodology preferred.
* Bachelor's degree in a science-related discipline preferred.

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