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High-Quality Assurance Position
3 weeks ago
Quality Assurance Specialist
Job Description:The selected candidate will be working on a cutting-edge fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US. This role presents an opportunity to support multiple capital projects taking place onsite in Carlow.
Key Responsibilities:- Perform routine testing in support of manufacturing and batch release with high-quality documentation.
- Review microbiological test data from utilities and environmental monitoring samples.
- Manage assay processes, ensuring controls/reference, standard stock control, and laboratory housekeeping standards are maintained.
- Ensure Standard Operating Procedures (SOPs) and forms are up-to-date with latest requirements and improvements.
- Support process simulations and work as part of a team.
- Minimum 1-2 years' experience within the pharmaceutical industry, preferably in sterile manufacturing microbiology lab environment.
- Knowledge of cGMP and GDP.
- Laboratory Quality Systems.
- Proficiency in Microsoft Office and job-related computer applications.
- Understanding of Lean six Sigma Methodology preferred.