Website Ref: TPM03508
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.
- 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.
To apply for this job email your details to firstname.lastname@example.org.