QC Bioanalytical Analyst is responsible for performing analytical testing within the Biologics laboratory. Monday to Friday role. Fully on site. 11 month contract.
Functions
1. Executing and Supporting routine analytical testing with assays such as HPLC Analysis (IEX, SEC, RPLC), UV analysis, Capillary Electrophoresis (CE), PCR testing, Bioassay methods (ELISA methods) and a wide range of compendial methods on Release, In-process, Stability samples in compliance with GMP requirements.
2. Executing and Supporting routine analytical testing with Raw materials onsite.
3. Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
4. Support the laboratory testing schedule to achieve an efficient QC system.
5. Receive and manage samples that come into the lab for stability, in-process and release testing.
6. Reagent preparation, cleaning, and routine equipment maintenance.
7. Maintain good housekeeping and hygiene within the laboratory.
8. Calibrate and maintain all designated laboratory instruments.
9. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
10. Ensure training is current for all job functions performed.
11. Order, stock and receive laboratory supplies.
12. Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
13. Ensure that cGMP standards are maintained at all times.
14. Promote and participate in the implementation and maintenance of the relevant safety programs.
Experience
1. 1 – 5 years laboratory testing experience in the Pharmaceutical industry.
2. Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
3. Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing, chemistry testing and raw material testing.
4. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
5. Knowledge of cGMP & Laboratory Quality Systems.
6. Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
7. Qualification in Science/Chemical Engineering/Biological Engineering.
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