Interim QC Technician

Interim QC Technician

Description

The purpose of this role is to support the activities of the CGT Catapult’s GMP Quality Control Laboratories and associated infrastructure. Reporting to the Quality Control Lead, this role will help ensure that the CGT Catapult Manufacturing Innovation Centre’s in Stevenage (SMIC) and Braintree (BMIC) meets the standards and expectations of its key stakeholders, regulatory authorities, and existing and potential new Collaborators.

Key Responsibilities

QC service delivery – e.g. environmental monitoring, raw material inspections/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

Perform routine viable and non-viable environmental monitoring in classified areas of the CGT Catapult MICs

Perform laboratory analysis and result reporting to assure service provision associated with viable environmental monitoring, excipient, in-process, final product sample testing, and raw material approval is maintained in line with the requirements of each collaborator and across the CGT Catapult MICs

Perform testing for biosafety, e.g., detection of microbial contamination by direct inoculation, detection of microbial contamination by BacT/Alert

Complete the testing as per GMP requirements

As required, work with QC personnel, QA, suppliers, and service providers to assist in the development and maintenance of GMP-compliant QC laboratory services across the CGT Catapult MICs

Undertake additional hours (including weekends and bank holidays) to meet operational demand

Willingness to travel to other CGT Catapult sites to support CGT Catapult MIC laboratory operations as required

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, media fills, etc

Provide support for environmental monitoring, plate reading, and speciation

Support other testing needs as identified from time to time by collaborator agreements

Support microbiological out of specification investigations

Regulatory compliance

Provide support to ensure that the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards

Provide support to ensure that all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity)

Provide support to ensure accurate, timely, and GMP-compliant completion of all documentation and records

Provide 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:

Proven experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment operating according to GMP

Experience of critically evaluating own work practices and procedures and identifying and highlighting any needed improvements

Skills, Knowledge and Expertise

Highly motivated, pragmatic and practical to support the mission of the CGT Catapult to assist in the acceleration of the development of a commercial cell-based therapy industry in the UK.

Self-motivated with excellent interpersonal, communication and presentation skills and the ability to prioritise effectively and work to tight deadlines

A “roll your sleeves up” hands-on attitude towards varying work assignments

Resilient, with the ability to manage multiple and varied tasks and prioritise workload for self and others within a fast-paced professional environment, with a strong attention to detail

Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and

priorities

Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks

Ability to solve problems and make informed decisions

Excellent technical writing skills and a high level of attention to detail

Project ownership and pride in its delivery

Having a passion for delivering excellent customer service

Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives

Ability to quickly establish credibility and build rapport and trust

A good team player with a hands-on approach, and adaptable to new challenges

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

Degree in Microbiology, Biotechnology, Molecular Biology, or related discipline