A global biologics company in Cork is looking for a QC Micro Analyst to perform day to day laboratory testing, data review, routine duties and capable of enthusiastically taking responsibility for ad-hoc duties and projects. While working cooperatively 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.
- Ensures that laboratory objectives are effectively achieved consistent with requirements to ensure compliance, safety and reliable supply to our customers.
- 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.
- Demonstrates awareness of safety for self and others in all aspects of work.
- Understands analysis of data generated in the lab.
- Maintains laboratory housekeeping standards.
- Must have strong scientific and GMP documentation skills.
- Understands Pharmacopoeias and guidelines and how to find and follow relevant information.
- Required to 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.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
- Reports to Microbiology laboratory Manager.
Qualifications & Experience:
- 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.
- Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.
- Focus on Customers and Patients.
- Demonstrate Ethics and Integrity.