A fantastic opportunity has arisen for an experienced senior QC Analyst to join a busy analytical team within a leading biopharmaceutical company in South Dublin on a 12-month contract with the possibility of extension.
Responsibilities:
• Testing of in-process, stability and finished product samples. For example, HPLC, CE, SDS-PAGE, IEF analytical testing, characterization and sample and data management.
• Review and authorization of Lab Data
• Support Analytical Technical Transfer activity testing reports and documentation.
• Document review/updates when required.
• Equipment Calibration, Maintenance and Trouble Shooting.
• Method Validation/Verification.
• Training of QC Chemistry Laboratory colleagues.
• Laboratory Investigation support
• Laboratory Housekeeping and maintaining GMP standards.
• Assisting in regulatory audits.
Qualifications & Experience:
• Hold a third-level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology Biotechnology or similar Scientific Subject.
• 3 - 5 years relevant experience in a pharmaceutical/healthcare environment
• Experience with analytical techniques such as HPLC, CE, SDS-PAGE, IEF testing is required.
• Be very proficient in the use of Microsoft Word, Excel etc.
• Have strong technical writing skills.
• Be detail-oriented, self-motivated with good troubleshooting and problem-solving abilities
• Be a self-starter and capable of working on own initiative
• Strong team work skills.
• Proven track record of meeting deadlines.
Top Skills:
• Significant experience in executing HPLC
• GMP lab experience essential, biopharmaceutical experience an advantage.
• Software experience in LIMS/LMES and Empower as this is used for execution of the HPLC.