QC Lab Microbiologist
Job title: QC Lab Microbiologist
Location: Fannin LIP Galway
Reporting to: Quality Lead
Principal Duties and Responsibilities:
Support Quality Management, and 17025 ISO certification for Fannin LIP Galway through activities such as:
- Perform tests and reporting of results as per product specifications
- Support, develop and implement QC procedure, processes and systems
- Assist with the development of in-house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files etc.
- Adhere to QC documentation system
- Perform weekly testing of R.O. water used for manufacturing
- Ensure culture maintenance – organisms from LGC – ATCC and Public Health England – NCTC
- Carry out environmental monitoring for specified manufacturing areas and the QC laboratory
- Perform competency and EQA testing as required
- Support consumables management
- Provide Microbiological support to the site
- Perform or support equipment calibration and verification
- Support issues management (Non-Conformances, Complaints, Vigilance, and Recalls or FSCA)
- Participate in and responsible for QC related CAPA’s
- Prepare for and support accreditation, regulatory and customer inspections and audits
- Support projects and continuous improvement initiatives within the Quality department and other department areas
- Adhere to safety requirements to ensure a safe working environment for all team members
- Adhere to accreditation requirements under ISO17025 and ISO9001
Qualifications & experience:
- Relevant third level qualification,
- Knowledge and proficiency in an array of microbiological techniques
- Knowledge of ISO standards associated with laboratory activities
Desirable:
- Experience in ISO 17025, ISO 15189, ISO/TR 22869
- Experience in Antimicrobial susceptibility testing
- Test method validation, process validation and Risk management experience
- Environmental monitoring experience
Personal Characteristics and Experience Profile Required
The principal skills, experience and personal characteristics, which the successful candidate will be able to demonstrate are:
- Pro-active,
- Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- Strong oral and written communication skills,
- Strong interpersonal skills,
- Ability to plan and prioritize work to meet commitments aligned with organizational goals.