Qc specialist ftc Work, Jobs in Harston, Cam (with Salaries)

QC Specialist - FTC
Cell and Gene Therapy Catapult —Stevenage
- Customer service
- Laboratory experience
- Bachelor's degree
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2d

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QC Specialist - FTC
Cell and Gene Therapy Catapult —Stevenage
Provide support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of…
Quick apply
2d
QC Manager
Stephen Walters and Sons Ltd —Sudbury
Experience leading or supporting teams within a manufacturing or quality-focused environment. A practical, collaborative, and hands-on approach with willingness…
£37,000 - £44,000 a year
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QC Specialist - FTC

Cell and Gene Therapy Catapult
Stevenage

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Job details

Fixed term contract
2 days ago

Qualifications

Biology
Microbiology
Customer service
Laboratory experience
Bachelor's degree
Organisational skills
IT
Communication skills

Full job description

Description

The Quality Control Specialist will support the activities of CGT Catapult’s GMP Quality Control Laboratories and associated infrastructure and will help ensure that the CGT Catapult Manufacturing Innovation Centres (MICs) in Stevenage and Braintree meet and operate to the standards and expectations of its key stakeholders, regulatory authorities, and potential Collaborators.

Key Responsibilities

QC Service Support – e.g. Environmental monitoring, microbiology, testing of raw material, in-process material tests, final product testing etc
Support the tactical execution of laboratory analysis and result reporting to ensure the QC service provision is maintained in line with the requirements of each Collaborator
Lead technical transfer, validation and routine execution of analytical techniques used for the manufacture, testing, and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA
As required work with the wider QC team, QA, suppliers and service providers to assist in the development and maintenance of GMP compliant QC Laboratory services and systems
Prepare, review and report process trending charts for QC activities
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 CGT Catapult derived microbiology and environmental monitoring samples, and manufacturing process and drug substance/product samples requiring testing
Support Collaborator raw material sampling activity and ensure it is undertaken to GMP standards and in accordance with Collaborator requirements
Support the continued use and configuration, as required, of the electronic laboratory information management system (LIMS) in accordance with the requirements of GMP
Leadership and line management supporting a growing group of QC Technicians
Manage QC scheduling and resource allocation ensuring efficient operation

QC Service:

Conduct test verifications and analytical method qualifications as required
Provide support for aseptic process qualifications, e.g. aseptic gowning, good aseptic practices and media fills etc
Conduct Out of Specification and other laboratory investigations
Provide training and guidance to the QC team and oversee routine activities to ensure the services are delivered in compliance with GMP standards and other QMS elements

Regulatory Compliance:

Provide support to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards
Provide support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity)
Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc. in compliance with applicable regulatory requirements for the service
Provide support to ensure the CGT Catapult QC team and associated service providers complete all documentation and records accurately, contemporaneously, and to a consistent GMP standard
Provide support to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity
Lead Change Controls, Out of Trend, Out of Specification and Deviation management events associated with QC services and assist in the implementation, 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, at similar responsibility level
Demonstrable experience of writing, executing and reviewing GMP documents and processes, including validations, autonomously
Proven experience of working in grade B/C cleanroom in a GMP facility
Demonstrable experience of working with relevant laboratory test platforms including operation and troubleshooting e.g. ELISA, Endotoxin testing, Sterility testing, Flow Cytometry, qPCR, ddPCR, Cell viability testing etc. in a commercial setting
Demonstrable experience with interacting with the regulatory authorities would be desirable
Demonstrable experience with interacting with clients and collaborators would be desirable

Knowledge / Skills / Competencies:

Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK
Motivation to build a career in the cell and gene therapy sector and contribute to its commercial success
Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment, whilst maintaining a high standard of work and meeting deadlines
High level interpersonal and communication (oral and written) skills, with the ability to engage and influence stakeholders, build rapport, establish credibility, and apply diplomacy across diverse internal and external groups
Accurate with strong attention to detail
Strong organisational skills with a sense of ownership and accountability for project delivery
Project ownership and pride in its delivery; strong organisational skills
Having a passion for delivering excellent customer service
Flexible and adaptable to changing priorities, work assignments, and new challenges
Ability to work independently, take initiative, and operate autonomously once objectives are set, including under pressure
Ambitious, collaborative, driven
Understanding of appropriate use of escalation processes
Proficient in Microsoft 365 applications and general IT systems
A positive attitude towards learning, personal and professional development
Keeps up to date with professional knowledge, expertise and best practice
Willingness to travel as required by the role

Education / Qualifications:

Bachelors or higher degree in relevant biology subject

About Cell and Gene Therapy Catapult

Cell and Gene Therapy Catapult (CGT Catapult) is an independent innovation and technology organisation committed to the advancement of the cell and gene therapy industry. CGT Catapult’s vision for the UK Industry is: globally-leading companies delivering transformative medicine to the world. Its mission is to create a pathway to accelerate breakthrough research in advanced therapies to commercialisation and scale. CGT Catapult works with Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.

CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone’s contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.

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