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Cell and Gene Therapy Catapult
Interim QA Associate (15 Month FTC)Cell and Gene Therapy Catapult • Stevenage, England, UK
Interim QA Associate (15 Month FTC)

Interim QA Associate (15 Month FTC)

Cell and Gene Therapy Catapult • Stevenage, England, UK
21 days ago
Job type
  • Temporary
Job 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)

Required Experience:

IC


Employment Type : Contract
Experience: years
Vacancy: 1
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Interim QA Associate (15 Month FTC) • Stevenage, England, UK

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