QC Separations Analyst
We are seeking a skilled QC Separations Analyst to join our team at an award-winning Pharmaceutical organization in Cork.
This is an excellent opportunity for anyone looking to work with a leading multinational company that is renowned for its excellence in the industry.
Duties:
* Achieve high levels of competency in laboratory methods and procedures to support in-process and release testing of biotechnology products.
* Review and approve laboratory test results.
* Perform analytical testing activities related to method validation and technical transfer to ensure compliance with ICH, USP, and EP guidelines.
* Execute validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software.
* Write and execute reports, review IQ/OQ and PQ protocols to qualify equipment for cGMP use.
* Ensure all testing is completed, reviewed, and approved within agreed turnaround times.
* Ensure QC activities are carried out in compliance with product license commitments, cGMP, and company quality standards.
* Train other QC analysts in laboratory methods and procedures as required.
* Write, update, and review Technical Memoranda (TMs), Standard Operating Procedures (SOPs), and Work Instructions (WIs).
* Write and review invalid assays, non-conformances, and deviations as required.
* Participate actively in lean initiatives such as Kaizen, 6S, and Gemba.
* Contribute to the QC group and provide assistance with other group activities as required.
* Communicate relevant issues to the QC Team Leader promptly.
* Maintain and develop knowledge of analytical technology and cGMP standards.
Education & Experience:
* Bachelor's degree (Honors) in a scientific or technical discipline.
* At least 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
* Experience with HPLC, Capillary Electrophoresis, UPLC/Mass Spec.