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Quality Control Technician

The purpose of this role is to support the activities of the Cell and Gene Therapy Catapult’s GMP Quality Control Laboratories and associated infrastructure. Reporting to the Head of Quality Control, this role will help ensure that the Manufacturing Centre meets the standards and expectations of its key stakeholders; regulatory authorities; and potential collaborators.

Key Accountabilities:

QC Laboratory Support – e.g. Environmental monitoring, raw material inspections/testing, in-process, final product and sterility testing:

  • Support the tactical execution of laboratory analysis and result reporting to assure the QC service provision associated with viable environmental monitoring, starting material, raw material, excipient, in-process and final product sample testing is maintained in line with the requirements of each collaborator.
  • As required work with QC personnel, QA, suppliers and service providers to assist in the development and maintenance of GMP compliant QC Laboratory services.
  • Undertake non-guaranteed overtime as per the Company policy in response to an operational need.

QC Sample Management & LIMS Management:

  • Support the Sample Management function to ensure the QC group provides a timely, effective and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of collaborator and CTG derived microbiology and environmental monitoring samples requiring testing.
  • Support collaborator raw material sampling activity and ensure it is undertaken to GMP and in accordance with collaborator requirements.

Microbiology:

  • Conduct environmental monitoring of the allocated area as per scheduling.
  • Undertake the Microbiological analysis according to specifications and methods.
  • Report the progress of daily activities to the Senior Technician/QC Specialist
  • Support microbiological Out of Specification investigations.

Regulatory Compliance:

  • Support to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
  • Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
  • Support to ensure the CGT team and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standard.
  • Support to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity.
  • Participate in Out of Trend, Out of Specification and Deviation management events associated with QC activity and assist in the reporting and management of such events to an appropriate and compliant conclusion.

Experience:

  • Experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment operating according to GMP.
  • Experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements.

Knowledge / Skills / Competencies:

  • Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to assist in the acceleration of the development of a commercial cell based therapy industry in the UK.
  • Project ownership and pride in its delivery.
  • Having a passion for delivering excellent customer service.
  • Flexibility towards work assignments and new learning.
  • Ability to manage multiple and varied tasks and prioritise workload with attention to detail.
  • Comfortable operating autonomously once goals and objectives are set.
  • Excellent interpersonal, written and verbal communication skills.
  • Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
  • Having current and up to date professional knowledge, expertise and best practice.
  • Ability to quickly establish credibility and build rapport and trust.
  • A good team player, with strong organisational skills.
  • Desire to establish a high profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success.
  • Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks.
  • Ambitious, collaborative, driven.
  • Comfortable operating autonomously once goals and objectives are set.
  • Accurate with strong attention to detail.
  • Ability to quickly establish credibility and build rapport and trust.
  • Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs.
  • A positive attitude towards learning, personal and professional development.
  • Keeps up to date with professional knowledge, expertise and best practice.
  • Willingness to travel.

Education / Qualifications

  • Bachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline.