Quality Assurance Specialist

Deeside, Flintshire

ADCBio is an innovative biotechnology company developing new process technology to speed, simplify and significantly lower the production costs of the latest generation of anti-cancer blockbuster drugs, Antibody Drug Conjugates (ADCs). Formed in 2010, ADCBio have recently secured significant investment that is enabling a new dedicated 6500m² facility in Deeside to support the rapid extension plan of the Company.

Reporting to the Quality Assurance Manager, the Quality Assurance Specialist is responsible for ensuring there is adequate QA support for production activities (including batch review), oversight of material management and approval of materials / service providers, approval of validation documentation and maintaining the quality management systems.

Key Responsibilities:

  • Assisting in the setting up of the ADC quality management system, document management, templates and compliance activities
  • Establishing and presenting Quality Management Systems metrics to the site leadership team to promote continuous improvement
  • Support during customer and regulatory audits
  • Supporting the review of all batch related documentation
  • Supporting quality related investigations
  • writing investigation reports and initiating/following up on corrective and preventative actions
  • Leading Quality based projects
  • Approving pre and post execution validation documents
  • Supporting material management processes to ensure materials are of the correct quality and are sourced from approved suppliers
  • Supporting batch release of clinical and commercial bulk drug substance / API against product specification files.
  • Ensure that all stages of Good Manufacturing Practice (GMP) are in full compliance with the principles of Good Practice guidelines and other regulatory requirements.
  • Perform self-inspection audits, and ensure any deficiencies are highlighted and then adequately mitigated


Skills and Qualifications:

  • HND Biological subject or in excess of 5 years working within a Quality Assurance department.
  • Minimum 3 years’ experience in a QA or QC role within either Pharmaceuticals or Biopharmaceutical environment.
  • Experience using Microsoft Office suite of programs
  • Knowledge and practical experience of GMP & GLP
  • Numerical & investigative skills
  • Ability to work accurately, with attention to detail
  • Ability to prioritise and deal effectively with a varied workload
  • Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
  • Approachable and friendly, with the confidence to challenge results and performance when required.

ADCBio offer a generous benefits package including a competitive salary (negotiable depending on experience and qualifications) plus 25 days holiday + statutory (+ death in service and private medical cover following a qualifying period).

Please apply by emailing a copy of your CV along with a covering letter detailing your current remuneration package.




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