QC Separations Analyst

Orion Group Life Sciences are currently recruiting a QC Separations Analyst on behalf of our Multinational Pharmaceutical Client based in Ringaskiddy, Cork on an initial 12-Month contract with potential to extend.

This position is responsible for carrying out tasks and projects related to testing procedures, equipment and lab utilities as required by Good Manufacturing Practice (GMP).
Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

Key Responsibilities:

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

Education and Experience/Competencies:

• BSc (Honors) in a scientific/technical discipline.
• A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
• HPLC.
• Capillary Electrophoresis.
• UPLC/Mass Spec (desirable).
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Excellent communication skills both written and verbal.
• Good knowledge of LIMS, Trackwise and Electronic documentation systems.
• Good knowledge of Microsoft Office applications such as word, Excel, PowerPoint
• Experience working in a high throughput laboratory environment.
• Excellent technical writing skills.
• Customer focus.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.