At a Glance
- Tasks: Support the setup of a new lab and ensure quality processes are in place.
- Company: Join a dynamic team at a leading diagnostic company.
- Benefits: Gain hands-on experience, competitive pay, and opportunities for growth.
- Other info: Collaborate with talented scientists and be part of an exciting journey.
- Why this job: Make a real impact in quality assurance and lab development.
- Qualifications: Bachelor's in science or relevant experience in quality roles.
The predicted salary is between 32000 - 40000 £ per year.
The Opportunity: Carries out a range of complex scientific support tasks at customer facilities, requiring significant interpretation of technical/scientific protocols to support.
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.
Qa Associate in Cambourne employer: Avantor
Avantor is an excellent employer, offering a dynamic work environment in the heart of Cambridge, where innovation thrives. Employees benefit from a competitive salary, a strong focus on professional development, and the opportunity to contribute to groundbreaking research while ensuring compliance with Health and Safety standards. With a culture that values attention to detail and teamwork, Avantor fosters a supportive atmosphere for growth and collaboration.
