We are seeking a highly skilled QC Bioanalytical Analyst to join our team at Life Science Recruitment. The successful candidate will be responsible for performing analytical testing within the Biologics laboratory.
Key Responsibilities:
* 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.
* Executing and Supporting routine analytical testing with Raw materials onsite.
* Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
* Support the laboratory testing schedule to achieve an efficient QC system.
* Receive and manage samples that come into the lab for stability, in-process and release testing.
* Calibrate and maintain all designated laboratory instruments.
* Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
* Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
* Ensure that cGMP standards are maintained at all times.
Requirements:
* 1 - 5 years laboratory testing experience in the Pharmaceutical or Biopharmaceutical industry.
* Qualification in Science/Chemical Engineering/Biological Engineering.
* 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.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Knowledge of cGMP & Laboratory Quality Systems.