QA Associate

QA Associate – Cambridge

12-months contract

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

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

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!

#LI-Onsite

Disclaimer:

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.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.