QC Microbiology Technician

Summary:
A biotech company in Carlow seeks a QC Microbiology Technician to join their Quality team. The successful candidate will perform day to day laboratory testing, data review and routine duties. The incumbent will demonstrate the capability of being a Subject Matter Expert in several assays & ensure that laboratory objectives are effectively achieved consistent with company requirements to ensure compliance, safety and reliable supply to their customers. This is a 2 cycle shift role.

Responsibilities:

• Perform any assigned aspect of routine testing in support of manufacturing and batch release with high quality of documentation RFT and technical writing.
• Perform 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 demonstrate the organisational skills to manage all aspects of a given assay e.g.; controls/reference, standard stock control etc.
• Ensure SOPs/forms are up to date with latest requirements and improvements/optimizations/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.
• Strong scientific and GMP documentation skills.
• Understand Pharmacopoeias and company guidelines and how to find and follow relevant information.
• Comply with Global and regulatory Requirements and execute current good manufacturing practices (cGMP) in the performance of day to day activities and all applicable job functions.
• May be required to perform other duties as assigned.

Qualifications & Experience:

• Bachelors degree preferred, ideally in science related discipline.
• Minimum of 1-2 year’s 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.
• High standard of quality.
• Demonstrate initiative.