Orion Group Life Sciences is recruiting a QC Chemist for 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 quality control commercial group, supporting bioanalytical and analytical testing plans across multiple products. This role is pivotal in terms of execution and delivery for the business and supports test and release of priority lots.
Key Responsibilities:
1. Supports testing of finished product across various techniques for the solid oral dosage, sterile, and biologic product portfolio.
2. Reviews analytical data and documentation to ensure compliance with appropriate specifications and protocols.
3. Supports reviews and investigations for out-of-trend/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 quality control and cross-functional projects as required.
8. Assists in training of QC staff.
9. Writes and revises methods, specifications, and SOPs as needed.
Requirements:
* Chromatographic separations experience in UPLC/HPLC and Empower.
* Technical writing (protocols, reports, procedures).
* Able to analyze data with logical approach to problem solving and troubleshooting.
* Excellent spoken and written communication skills.
* Proficient in Microsoft Office.
* Working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry.
Education & Experience:
* BSc degree in analytical Biochemistry or equivalent.
* Prior experience in the pharmaceutical industry preferred.