Orion Group Life Sciences are currently recruiting a QC Chemist on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 12-Month contract with potential to extend.
The QC Chemist will be part of the QC Commercial group supporting Bioanalytical and analytical testing plans across multiple products. This is a pivotal role in terms of execution and delivery for the business and supporting test and release of priority lots. The role supports activities related to structured problem solving, technical support for laboratory investigations, and support teams such as safety, 5S, Good Lab Practices, and training.
Job duties include:
1. Supports testing of finished product across a variety of techniques for the solid oral dosage, sterile and biologic product portfolio.
2. Review of analytical data and documentation to ensure compliance with appropriate specifications and protocols.
3. Supports reviews and investigations for out-of-trends/out-of-specifications.
4. Participates in validation and commercial/developmental manufacturing activities.
5. Troubleshoots standard instrumentation/test methods.
6. Coordinates waste management, LEAN/Operational excellence, and 5S efforts as required.
7. Participates in QC and cross-functional projects as required.
8. Assists in the training of QC staff.
9. Writes and revises methods, specifications, and SOPs as needed.
Knowledge, Experience and Skills:
1. Chromatographic separations experience in UPLC/HPLC and Empower.
2. Technical writing (protocols, reports, procedures).
3. The ability to analyze data with a logical approach to problem solving and troubleshooting.
4. Excellent spoken and written communication skills.
5. Proficient in Microsoft Office.
6. Working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
Education & Experience:
1. BSc degree in analytical Biochemistry or equivalent.
2. Prior experience in the pharmaceutical industry is preferred.
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