QC Separation Analyst

23 hours ago

Cork, Ireland Life Science Recruitment Full time

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

1. Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.
2. Review and approval of laboratory test results.
3. Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
4. Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
5. Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
6. Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
7. Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
8. Trains other QC analysts in laboratory methods and procedures when required.
9. Writes/updates and reviews TMs, SOPs and WIs as required.
10. Writes and reviews invalid assays, non-conformances and deviations as required.
11. Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba.
12. Is an active member of the QC group and provides assistance with other group activities as required.
13. Communicates relevant issues to the QC Team Leader promptly.
14. Maintains and develops knowledge of analytical technology as well as cGMP standards.

Education & Experience

1. BSc (Honors) in a scientific/technical discipline.
2. 2 years’ experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
3. HPLC, Capillary Electrophoresis, UPLC/ Mass Spec experience.

If interested in this posting please feel free to contact Sean McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.

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