At a Glance
- Tasks: Support the setup of a new lab and ensure quality processes are in place.
- Company: Avantor, a leader in life-changing science and diagnostics.
- Benefits: Join a diverse team with opportunities for career growth and impactful work.
- Other info: Collaborative environment with a focus on continuous improvement.
- Why this job: Make a real difference in diagnostic development and quality assurance.
- Qualifications: Bachelor's in science or equivalent experience in a quality role.
The predicted salary is between 35000 - 45000 £ per year.
The Opportunity:
Are you passionate about quality, compliance, and building processes from the ground up? We are looking for a QA Associate to join our growing team and play a key role in establishing and maintaining our Quality Management System (QMS). This is a unique opportunity to support the setup of a brand-new laboratory environment, where you will contribute to the validation and development of diagnostic assay tests, while ensuring robust quality practices are embedded from day one.
Key Responsibilities
- Review, evaluate, and approve document changes in line with established procedures
- Manage documentation within the electronic Quality Management System (eQMS), ensuring accuracy and compliance
- Support training coordination and assignment for employees
- Partner closely with Operations and Scientific teams to ensure work is performed in accordance with quality standards
- Confidently explain and defend QA processes and documentation to scientists and cross-functional teams
- Process complaints and nonconformances, ensuring accurate and compliant record keeping
- Assist in CAPA (Corrective and Preventive Actions) activities
- Support change control processes and documentation
- Monitor, evaluate, and report key quality performance indicators (KPIs) related to lab quality
- Participate in supplier evaluations and maintain supplier records
- Collaborate cross-functionally to resolve routine quality issues identified during inspections
- Contribute to internal audit activities and continuous improvement initiatives
What You Bring
Essential Qualifications & Skills:
- Bachelor's degree in a science-related field, or equivalent experience in a quality role within a clinical lab environment
- Experience supporting documentation processes within a regulated environment
- Proven ability to work with computer systems, including databases and Microsoft tools
- Excellent communication skills, with the confidence to engage with and support scientific teams
- Strong organizational, analytical, and time management abilities
- High attention to detail and a proactive, solution-focused mindset
- Collaborative approach with the ability to build strong working relationships
Nice to Have:
- At least 2 years of hands-on quality experience in the medical device or IVD industry
- Experience working in lab start-up or scale-up environments, particularly supporting assay development and validation
- Basic understanding of FDA Quality System Regulations (QSR) and applicable ISO standards
Why Join Us?
- Be part of an exciting lab build and scale-up journey
- Work at the forefront of diagnostic assay development
- Collaborate with talented scientists and cross-functional teams
- Make a tangible impact by shaping quality processes from the ground up
If you're a proactive QA professional who thrives in a fast-paced, evolving environment and enjoys working closely with scientific teams, we'd love to hear from you!
QA Associate in Croxton employer: Avantor
Avantor is an exceptional employer that offers a unique opportunity to be part of a pioneering lab build and scale-up journey in Cambridge. With a strong commitment to employee growth, a diverse and inclusive culture, and the chance to collaborate with talented scientists, you will play a vital role in shaping quality processes that have a real impact on patient outcomes. Join us to advance your career while contributing to life-changing science in a supportive and dynamic environment.
