Quality Control Associate

1 month ago

London, Greater London, United Kingdom Great Ormond Street Hospital for Children NHS Foundation Trust Full time

Job Overview

Quality Assurance Associate - Advanced Therapeutics Division

An exceptional opportunity has arisen within the Advanced Therapeutics Division at Great Ormond Street Hospital for Children NHS Foundation Trust for a Quality Assurance Associate role. We take pride in being part of a nationally recognized center of excellence in providing specialized healthcare for children, currently offering the most extensive range of specialized services among children's hospitals in the UK.

The Advanced Therapeutics Division is responsible for producing life-saving treatments for pediatric patients under the regulations of the MHRA. Our cutting-edge, purpose-built facility is licensed by the MHRA, enabling us to operate under the stipulations of our MIA(IMP) and MS licenses.

The Quality Assurance Associate will provide support and guidance to the manufacturing team in the creation, evaluation, and endorsement of essential documentation utilized in the manufacture of Advanced Therapy Medicinal Products (ATMPs). The successful candidate will lead a team of Senior QA technicians to ensure the thorough review of batch manufacturing records following production and prior to QP certification. Additionally, the postholder will ensure that all manufacturing quality records and relevant QA activities are managed in accordance with internal processes and regulatory standards.

Key Responsibilities

As a member of the Quality Assurance team, the postholder will collaborate closely with the Production and Manufacturing teams to integrate quality into departmental operations, assist staff with their training requirements, and ensure that all work is conducted in compliance with local, national, and professional standards as well as regulatory guidelines.

We are seeking a candidate with a robust background in Quality Assurance, a thorough understanding of Good Manufacturing Practice (GMP) principles, and prior experience in the ATMP sector. The ideal candidate should exhibit strong leadership and management skills, exceptional organizational abilities, meticulous attention to detail, and effective problem-solving capabilities. Proficient communication skills, both written and verbal, are essential for effective collaboration with internal teams and external stakeholders.

This position offers a wonderful opportunity to join our supportive and diverse Quality team, which boasts a wide range of skills and experiences. We look forward to receiving your application.

About Us

Great Ormond Street Hospital is dedicated to recruiting the most qualified individuals for each role, based solely on their abilities and merits as assessed against the role's criteria. We are committed to a recruitment process that is fair, transparent, consistent, and free from bias. We strive to be a diverse and inclusive employer, fostering a culture where all staff members are valued, respected, and acknowledged. All applicants will be considered for employment without regard to race, color, national origin, religion, sexual orientation, gender, gender identity, age, disability status, or any other characteristic. We particularly welcome applications from BAME communities, individuals with disabilities, and members of the LGBT+ community. We have established policies and procedures to ensure that all applicants and employees are treated fairly and consistently.

Essential Qualifications and Experience

  • Educated to BSc level in a relevant scientific discipline
  • Training in Quality Management Systems (QMS), Quality Assurance, or relevant experience
  • Postgraduate qualification in an appropriate specialty or equivalent experience
  • Demonstrated practical knowledge of QA, GMP, GCP, and all relevant regulations
  • Strong understanding of cell and gene therapies
  • Experience working in a QA environment
  • Familiarity with QMS management, including deviations, change controls, CAPAs, and QRAs
  • Proven experience in QA review of manufacturing batch-related documentation
  • Knowledge of qualification and validation requirements for ATMP products
  • Experience in training delivery
  • IT proficiency (Word, Excel, PowerPoint)

Skills and Abilities

  • Strong organizational skills with the ability to prioritize and meet deadlines
  • Excellent problem-solving abilities
  • High attention to detail and accuracy
  • Strong verbal and written communication skills
  • Ability to follow written and oral instructions accurately
  • Capacity to work independently and collaboratively within a team
  • Experience in personnel management and staff training
  • Initiative and willingness to support colleagues
  • Self-motivated with a positive attitude

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