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Quality Assurance Analyst Biologics
2 weeks ago
PSC Biotech is a leading biotech consultancy firm seeking a Quality Assurance Analyst Biologics to join our team. Our company provides cloud-based software solutions for Quality Management and Regulatory Inspections.
Job OverviewThe Quality Assurance Analyst Biologics will be responsible for performing analytical testing within the Biologics laboratory. This role requires experience in laboratory testing and knowledge of cGMP and Laboratory Quality Systems.
Key Responsibilities- Execute and support 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.
- 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.
- Reagent preparation, cleaning, and routine equipment maintenance.
- Maintain good housekeeping and hygiene within the laboratory.
- 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.
- Ensure training is current for all job functions performed.
- Order, stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Promote and participate in the implementation and maintenance of the relevant safety programs.
