Quality Release Specialist

Quality Release Specialist focuses on managing day‑to‑day activities within the quality management system (qms), partnering with cross‑functional teams to investigate.

What the role involves

• Managing day‑to‑day activities within the Quality Management System (QMS), partnering with cross‑functional teams to investigate.
• Review and close quality records within the electronic QMS.
• Review and approve quality documentation, including SOPs, work instructions and forms, ensuring compliance with Good Documentation Practice.
• Investigate quality issues and customer complaints, working collaboratively to identify root causes, prioritise actions and implement pragmatic, compliant solutions.
• Support quality‑related training, and influence others to achieve quality objectives.
• Communicate quality system requirements effectively to employees.

Skills and requirements

• Degree in Life Sciences, Pharmacy or Chemistry (or equivalent).
• Experience in a Quality Assurance or related role.
• Knowledge of GMP and GDP guidelines for human medicinal products.
• Understanding of WDA(H), MS and MIA(IMP) licence requirements.

Confirmed role details

• 27 days holiday plus 8 bank holidays.
• Pension contributions 4.5% matched.
• Life assurance 4 x annual.

Candidate fit

• We are seeking a proactive and detail‑driven Quality Release Specialist to support our Quality and Warehouse teams.

Additional role context

• We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa.
• Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.