Join the team that keeps quality at the core-where every test protects product integrity.
Proclinical is seeking a QC Analyst to join a dynamic team in Ireland. In this role, you will be responsible for conducting analytical testing and ensuring that all products meet the required standards for cGMP operations. This position focuses on sample testing, data integrity, and compliance with quality and safety standards.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Perform analytical testing on intermediate production samples, final product samples, and environmental samples within committed schedules.
2. Conduct raw material testing, stability testing, assay transfers, and instrument qualification.
3. Record all raw data, calculations, and information related to tasks to ensure compliance with cGMP and data integrity requirements.
4. Review QC data from executed tests by other analysts in a timely manner.
5. Ensure proper training and qualification for assigned analytical testing tasks.
6. Notify management promptly of any quality or HSE events, deviations, or out-of-specifications (OOx) to facilitate appropriate investigations and impact assessments.
7. Actively participate in investigations and execute assigned CAPAs related to remediation plans and continuous improvements.
8. Maintain laboratory facilities and instruments in a safe and compliant state for appropriate use.
Key Skills and Requirements:
9. Strong understanding of cGMP and HSE requirements.
10. Proficiency in analytical testing and data review processes.
11. Attention to detail and commitment to maintaining data integrity.
12. Ability to manage time effectively and adhere to scheduled plans.
13. Experience in participating in investigations and implementing CAPAs.
14. Familiarity with laboratory equipment and quality control procedures.