Job Title:
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.
Requirements:
* 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.