Company Profile:
Here at Hays we have an outstanding opportunity with a leading biologics firm who are seeking a QC Chemist II on an initial 12-month contract to be based at their state-of-the-art facility in Cork city. The company has an array of promising new products in development targeting specific advances in the fields of virology, oncology, and inflammation.
Job Summary:
QC Chemist in QC Commercial group supporting bioanalytical/analytical testing supporting 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.
Responsibilities:
* Supports testing of finished product across a variety of techniques for the solid oral dosage, sterile and biologic product portfolio
* Review of analytical data and documentation to ensure compliance to appropriate specifications and protocols.
* Supports reviews and investigations for out- of trends/out–of specifications.
* Participates in validation and commercial/developmental manufacturing activities
* Troubleshoots standard instrumentation/test methods.
* Coordinates waste management, LEAN/Operational excellence and 5S efforts as required.
* Participate in QC and cross-functional projects as required.
* Assists in the training of QC staff.
* Writes and revises methods, specifications, and SOP’s as needed.
Qualifications and Skills:
* BSc degree in analytical Biochemistry or equivalent.
* Prior experience in pharmaceutical industry is preferred
* Chromatographic separations experience in UPLC/HPLC and Empower
* Technical writing (protocols, reports, procedures)
* The ability to analyse data with a logical approach to problem solving and troubleshooting
* Excellent spoken and written communication skills
* Proficient in Microsoft office
* Working knowledge of GMPs, GLPs, pharmacopeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
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