Senior QA Associate

Who is BioOra?
BioOra is proud to be New Zealand's first Chimeric Antigen Receptor (CAR) T-cell manufacturing company. At the forefront of cell therapy innovation, we are currently manufacturing for a Phase II clinical trial and advancing toward large scale commercial production. Our goal is to revolutionise cancer immunotherapy by automating and scaling the production of CAR T-cells, to deliver this life-saving technology at a fraction of standard costs and time.  
 
What will you do?
As we are now on the second half of our PHASE-2 of our clinical trial, we need a Senior QA Associate to help us maintain the highest possible standard as we continue to move forward. Reporting to our Quality Manager, you'll take a lead role in developing and monitoring our eQMS, ensuring strict adherence to quality and regulatory standards. Taking ownership of designated QMS workflows you'll ensure we are on track to meet deadlines. This encompasses:

• Document oversight for batch records and batch release process, reviewing high level documentation and carrying out document control activities
• Taking ownership of key QMS processes to keep them GMP compliant and improving existing quality processes
• Collaboration with the wider team to investigate deviations and quality incidents, as well as drafting associated reports.
• Developing and implementing CAPA plans that eliminate non-conformance.
• Investigation of non-compliances and/or product quality complaints.
• Assess risk and monitor trends through internal audits, risk assessments, analysing quality data, and completing PQRs as required.

Occasional rostered weekend work may be required.
 
What do you bring to the role?
Your expertise will set the standard in upholding our commitment to the highest standards and quality in our operations. Coming from a GMP environment, you will have a strong background in a similar Quality Assurance position, as well as a relevant scientific degree. Ideally you will have experience in pharmaceuticals or biotech or other highly regulated environment. It would be an advantage to have experience in microbiology.
You will have:

• A demonstrated working knowledge of Quality Systems processes and relevant GMP regulations
• A strong interest in compliance within the pharmaceutical or biotechnology industries
• The ability to clearly and concisely communicate technical information to a wide audience
• A proactive attitude, with a focus and drive to achieve goals that benefit the whole
• Impeccable attention to detail with sharp organisational skills
• Confidence in your understanding of QA, and a willingness to flag potential risks early

Why join us?
We are a values-based organisation, because we're creating something EPIC! Here's how...

• Excellence - We strive for the highest standards in everything we do
• Passion - We bring enthusiasm and dedication to our work
• Innovation - We embrace creativity and push boundaries
• Collaboration - We thrive together valuing every voice
• ! - We go the extra mile to make a difference!

When you apply
Every application is screened by a human who wants you to live up to your EPIC! application! 

• So if your purpose lies in making a meaningful difference in the fight against cancer, tell us why with an up-to-date CV and short introduction letter.
• As much as we know AI has its place, we're not fans when it comes to cover letters. We therefore ask for **no AI cover letters,**and with the number of applications we get it's very easy to tell if you do!
• Please, if you see more than one role advertised only apply onceour humans will assess fit across the organisation.

We'll also be checking you've answered the following question: What is your go to dish to bring to a potluck, and why will it be a crowd favourite?
 
Applications close Sunday 27th September 2026.
*Please note, to be considered for this role you MUST already have the legal right to work in New Zealand.