Job Description:
We are currently seeking a highly skilled Quality Control (QC) Analyst to join our team at an award-winning Pharmaceutical organization in Cork.
Main Responsibilities:
* Achieve a high level 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 in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
* Ensure that 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 when required.
* Write/updates and reviews TMs, SOPs and WIs as required.
* Write and review invalid assays, non-conformances and deviations as required.
* Actively participate in JSI lean initiatives such as Kaizen, 6S and Gemba.
* Be an active member of 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 as well as cGMP standards.
Requirements:
* BSc (Honors) in a scientific/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.