Job Title:
We are seeking a skilled Quality Control Analyst to join our team at an award-winning Pharmaceutical organization based in Cork.
Duties:
* Achieves high levels of competency in laboratory methods and procedures to support in-process and release testing of biotechnology products.
* Reviews and approves laboratory test results.
* Performs analytical testing activities related to method validation and technical transfer, ensuring compliance with ICH, USP, and EP guidelines.
* Executes validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software.
* Writes and executes reports, reviews IQ/OQ and PQ protocols to ensure relevant equipment is qualified for cGMP use.
* Ensures all testing is completed, reviewed, and approved within agreed turnaround times.
* Ensures QC activities comply with product license commitments, cGMP, and company quality standards.
* Trains other QC analysts in laboratory methods and procedures as required.
* Writes/updates and reviews TMs, SOPs, and WIs as necessary.
* Writes and reviews invalid assays, non-conformances, and deviations as needed.
* Participates actively in JSI lean initiatives such as Kaizen, 6S, and Gemba.
* Serves as an active member of the QC group, providing assistance with group activities as required.
* Communicates relevant issues to the QC Team Leader promptly.
* Maintains and develops knowledge of analytical technology as well as cGMP standards.
Requirements:
* BSc (Honors) in a scientific or technical discipline.
* 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
* HPLC, Capillary Electrophoresis, UPLC/Mass Spec experience.
Estimated Salary:
€45,000 - €60,000 per annum, depending on qualifications and experience.