Backroom associate Work, Jobs in Stevenage, Eng (with Salaries)

Interim QA Associate (15 Month FTC)
Cell and Gene Therapy Catapult —Stevenage
- Travel
- Communication skills
- Time management
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14h
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Interim QA Associate (15 Month FTC)

Cell and Gene Therapy Catapult
Stevenage

Quick apply

Job details

Fixed term contract
14 hours ago

Qualifications

Quality assurance
Communication skills
A Level
Time management

Full job description

Description

The Quality Assurance Associate will work within the QA team to support the operation and performance measurement of the Pharmaceutical Quality System (PQS) across the CGT Catapult MICs (Stevenage and Braintree), maintain documentation in all forms, support assessment of quality records, and provide training to personnel in core competencies.

Key Responsibilities

Perform QA functions within the eQMS (MasterControl / Ideagen)
Issue, review, and reconcile controlled documents to CGT Catapult departments and Collaborator organisations
Maintain QMS trackers and generate trends and graphs for effective monitoring of the health of the QMS by System Owners and Management
Engage with quality record owners to support right-first-time and on-time completion
Support with Collaborator and external regulatory inspection preparation (e.g. MHRA), including participation in the inspection “backroom” to provide documentation and records under strict timelines during inspection
Perform facility walkarounds, assessing compliance with established procedures
Review basic quality documentation such as Non-Conformances, CAPAs, Change Controls, and procedure updates
Support off-site archiving of departmental records (for example: logbooks, forms and reports)
Support the delivery of GMP training to internal colleagues and Collaborator personnel
Provide support to activities across the CGT Catapult MICs ) with attendance and periodic travel to the CGT Catapult to both

Experience:

Experience working in a GMP or Quality Assurance environment
Experience in the use and operation of an electronic QMS is advantageous
Experience in Biologics or ATMP, or Sterile manufacturing is advantageous

Skills, Knowledge and Expertise

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
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
High-level interpersonal, communication (oral and written) skills and emotional intelligence
A good team player with a hands-on approach, and adaptable to new challenges
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
Flexibility towards work assignments and new learning
Ambitious, collaborative, driven
Accurate, with a strong attention to detail
Planning and time management of tasks to ensure deadlines are consistently met, factoring in the potential of changing circumstances
Communicates with clarity and conciseness, understanding and adapting the message to engage different audiences
Retains an engaged and active mind through routine processes/ procedures to remain alert to anomalies or situations requiring further thought/ action
A positive attitude towards learning, personal and professional development
A positive attitude towards learning, personal and professional development
Keeps up to date with industry best practice
Willingness to travel

Education / Qualifications:

A-level science qualification
Degree in life sciences (advantageous)

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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Interim QA Associate (15 Month FTC)

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