We are currently seeking to recruit a QC Microbiology Analyst for our client, a global pharmaceutical leader. The successful candidate will perform day to day laboratory testing, data review, routine duties and be capable of taking responsibility for ad-hoc duties and projects.
· 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 review 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/forms are up to date with latest requirements and improvements/optimizations/lean.
· Supports process simulations
· Understands analysis of data generated in the lab. Maintains laboratory housekeeping standards
· Must have strong scientific and GMP documentation skills.
· Understands Pharmacopoeias and how to find and follow relevant information required to comply with regulatory requirements
Skills and Knowledge
· Diploma or higher preferred; ideally in a related discipline
· 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
· Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers