Quality Control Technician - Biosafety Testing

  • Cell & Gene Therapy Catapult
  • Job type: Permanent
  • Closing by 22/11/2019
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CT281_3_2019 - Quality Control Technician - Biosafety Testing

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Posted: 11/11/2019 10:07

Salary: Competitive

Location: Stevenage

Level: Manufacturing Centre

Deadline: 22/11/2019 17:00

Hours: 37.50

Benefits: Competitive

Job Type: Permanent

Purpose of Role:

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

Key Accountabilities:

QC Service Delivery – Biosafety testing:

Perform testing of collaborator materials as well as CGT samples when required for biosafety e.g. detection of mycoplasma by PCR, detection of Endotoxin, detection of microbial contamination by direct inoculation, detection of microbial contamination by BacT/Alert etc.

Complete the testing as per GMP requirements

Review data for accuracy before submission to Quality Control Specialist/QA

As part of the rotational cover, support the tactical execution of laboratory analysis and result reporting to assure the QC service provision associated with environmental monitoring in Grade B to D areas, starting material, raw material, excipient, in-process and final product sample testing using microbiology techniques, microbial identification endotoxin testing, Sterility Testing, mycoplasma testing by PCR, Cell count and viability testing, microscopy etc, is maintained in line with the requirements of each collaborator.

Perform Trend analysis of data and participate in periodic reviews of the services.

As required work with QC personnel, QA, suppliers & service providers to assist in the development and maintenance of GMP compliant QC Laboratory services.

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:

Provide support for aseptic process qualifications, such as aseptic gowning, good aseptic practices and media fills etc.

Support microbiological Out of Specification investigations.

Support other testing needs as identified from time to time by collaborative agreements.

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 aseptic (bio) pharmaceutical manufacturing environment and QC laboratory operating according to GMP using techniques described, for a minimum of 2 years.

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 prioritize 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.

Education / Qualifications:

Bachelor’s degree in Microbiology, Biotechnology, or related discipline

Apply now

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