This is an 11-month initial contract and is a 2-shift cycle, Purpose To perform day-to-day laboratory testing, data review, and routine duties and capable of enthusiastically taking responsibility for ad-hoc duties and projects.
While working co-operatively as part of a team, will demonstrate drive, initiative, and hunger for knowledge and quality of work.
Will be, or demonstrate the capability of being, a Subject Matter Expert in several assays.
Responsibilities Performs any assigned aspect of routine testing in support of manufacturing and batch release with high-quality of documentation RFT and technical writing Performs data review of microbiological test data from utilities and environmental monitoring samples.
Other data reviews may be performed in line with experience level and SME knowledge Clearly demonstrates the organisational skills to manage all aspects of a given assay e.g.
; controls/reference, standard stock control, etc.
Ensures SOPs/formsare up to date with the latest requirements and improvements/optimizations/lean.
Supports process simulations Works as part of a team Demonstrates awareness of safety for self and others in all aspects of work.
Understand the analysis of data generated in the lab.
Maintains laboratory housekeeping standards Must have strong scientific and GMP documentation skills.
Understands Pharmacopoeias and MSD guidelines and how to find and follow relevant information Required to comply with MSD Global and regulatory requirements and execute current good manufacturing practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture in Carlow May be required to perform other duties as assigned Qualifications Diploma or higher preferred; ideally in a related discipline Would typically have prior related work experience; ideally in a Microbiology Laboratory setting Knowledge of cGMP and GDP preferred Laboratory Quality Systems Proficiency in Microsoft Office and job-related computer applications required Understanding of Lean Six Sigma Methodology preferred Skills: Lab Testing Documentation SOPs Data Review Microbiology