Quality Assurance Specialist
This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
The successful candidate will be responsible for performing routine testing in support of manufacturing and batch release with high quality of documentation, RFT and technical writing.
Key Responsibilities:
* Perform any assigned aspect of routine testing
* Perform data review of microbiological test data from utilities and environmental monitoring samples
* Clearly demonstrate organisational skills to manage all aspects of a given assay
* Ensure SOPs/forms are up to date with latest requirements and improvements/optimisation's/lean
* Support process simulations
* Work as part of a team
* Demonstrate awareness of safety for self and others in all aspects of work
* Understand analysis of data generated in the lab
* Maintain laboratory housekeeping standards
Requirements:
* Minimum of 1-2 years' experience within the pharmaceutical industry (within Microbiology) – preferable in sterile manufacturing microbiology lab environment
* Knowledge of cGMP and GDP
* Laboratory Quality Systems
* Proficiency in Microsoft Office and job-related computer applications required
* Understanding of Lean six Sigma Methodology preferred
* Bachelor's degree preferred, ideally in science related discipline