Orion Group Life Sciences are currently recruiting 2 x Microbiology Quality Technicians on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-month contract (2-cycle shift).
The successful candidate will perform day to day laboratory testing, data review, routine duties and be capable of enthusiastically taking responsibility for ad-hoc duties and projects. They 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 customers.
Key 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/Education:
* Bachelor's degree preferred, ideally in science related discipline.
* 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.
* High standard of quality.
* Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.
* Demonstrate initiative.
#J-18808-Ljbffr