Quality Control Officer - Microbiologist

 Job Description:

The post holder will join a multi-discipline team tasked with the development and
manufacture of novel cell and gene therapy products. The Quality Control (QC) Officer’s duty would include activities relating to environmental monitoring, sampling collection, product testing and raw materials release.

The post holder will manage quality control testing activities conducted both externally sub-contracted and internally including associated documentation and data review. As part of a multi-discipline team involved in Gene Therapy product development and manufacture, the post holder will have a unique opportunity to be involved in translating cutting-edge biotechnology development into a clinically safe and regulatory compliant product.

The candidate will be reporting to the Head of Quality and will be working closely with the Production Department, Research and Development Department and Quality Assurance Officers to ensure all production facility is maintained at specified conditions and product QC meeting specifications.

The QC Officer will be expected to contribute to maintaining CellVec’s Good Manufacturing Practice standard in compliance to regulatory certification remit.

THE ROLE
  • Perform environmental monitoring such as active air sampling, surface and passive air samplings and inspection of cleaned facility and sterilized equipment
  • Outline processes and accountabilities for checking of particulates and contaminants
  • Assess the certification and accreditation requirements for external laboratories
  • Review test reports and develop guidelines and standard practices for data documentation and analysis
  • Write technical protocols and reports including environmental monitoring risk analysis
  • Develop method of analysis and specifications for materials, products and packaging
  • Drafting and updating of relevant Standard Operation Procedures
  • Review test results, document scientific data and produce trends in an efficient, organized and presentable manner to facilitate discussions, and to support business and performance metrics reporting
  • Conduct root cause analysis for product defects and quality lapses. Assist product quality related investigations and process deviations, investigations, and support internal and external inspections
  • Implement initiatives to encourage improvement of QC procedures, activities and workflows
  • Conduct routine literature and knowledge-based learning through established publication channels to ensure continual knowledge proficiency on both GMP and current technological trends relevant to CellVec’s activities
  • Deliver individual goals and tasks to agreed timelines as critical part of overall team objectives
  • Prior experience in external audits.

THE PERSON
  • A degree in Biotechnology / Pharmaceutical or Biological Sciences with at least 3 years working experience in biotechnology or pharmaceutical industries
  • Experience and track record in GMP cleanroom environmental monitoring and QC analysis
  • Knowledge in cell biology or molecular biology analysis an advantage
  Required Skills:

Environmental Procedures GMP Risk Analysis Performance Working Experience Data Product Quality Reports Development Support Literature Timelines Raw Materials Assurance ROOT Metrics Biology Analysis Product Development Quality Control Quality Assurance Inspection Specifications Manufacturing Materials Research Documentation Testing Business

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