QA Specialist

QA Specialist - Cell Therapy

Are you passionate about quality assurance and eager to make a difference in the cutting-edge field of cell therapy? We are seeking a dedicated and detail-oriented QA Specialist to join our innovative team.

About the Role:As a QA Specialist in our Cell Therapy division, you will play a crucial role in ensuring the quality, safety, and efficacy of our life-changing cellular therapies. You'll be responsible for maintaining our Quality Management System (QMS) and supporting our mission to deliver groundbreaking treatments to patients in need

Key Responsibilities:

• Execute manufacturing batch records, work instructions, and SOPs with a focus on 'right the first time' principles
• Monitor and maintain compliance with cGMP regulations and company standards
• Participate in deviation investigations and implement corrective and preventive actions (CAPAs)
• Review and approve manufacturing documentation and batch records
• Support tech transfer activities and continuous improvement initiatives
• Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle

Qualifications:

• Bachelor's degree in life sciences, biotechnology, or a related field
• 2-3 years of QA experience in the pharmaceutical or biotechnology industry, preferably in cell therapy or biologics manufacturing
• Strong knowledge of cGMP regulations and quality systems
• Excellent attention to detail and analytical skills
• Proficiency in Microsoft Office suite and quality management software
• Ability to work in a fast-paced, dynamic environment

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.