QA Associate in Newtown

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.

As a QA Associate, you will:

• 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
• 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

Qualifications:

• 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

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.