Job Title: QC Analyst – Quality Operations Laboratory
Location: Carlow-Onsite, Ireland
Role Overview:
As a QC Analyst, you will perform and review a range of analytical techniques as part of routine and non-routine testing to ensure that processes and products comply with regulatory and quality standards, facilitating product release. You will report to the QC Manager and work closely with cross-functional teams to maintain high-quality standards and compliance.
Key Responsibilities:
* Execute day-to-day laboratory-based duties as part of the QC team.
* Review and approve batch documentation, deviations, and investigation reports.
* Support audit readiness and compliance with cGMP, GDP, and regulatory requirements.
* Participate in internal and external audits and inspections.
* Perform and review analytical testing including HPLC, immunoassays, cell-based assays, and compendial methods.
* Support laboratory investigations, trend analysis, method validation, and equipment qualification.
* Drive continuous improvement, conduct root cause analysis, and resolve system or equipment issues using standard methodologies (e.g., FMEA, Fishbone, 5 Whys).
* Ensure effective communication of testing progress, deviations, and results within QC team meetings.
* Work collaboratively to foster a safe, compliant, and high-performing laboratory environment.
Qualifications & Skills:
* Bachelor's degree or higher in a science-related discipline preferred.
* 2-3 years of experience in a QC laboratory within the pharmaceutical industry.
* Knowledge of cGMP, GDP, and other regulatory requirements.
* Familiarity with laboratory quality systems and electronic tools (LIMS, SAP, MES).
* Strong attention to detail, communication, and teamwork skills.
* Immunoassay and cell culture experience is desirable.
* Understanding of Lean Six Sigma methodology is a plus.
Additional Requirements:
* Onsite role only (remote or hybrid not applicable).
* Must be willing to work a 4-cycle 12-hour shift pattern.