Quality Assurance (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 potentially life-saving technology to those who need it.  
 
What will you do? 
This QA role provides independent quality oversight of QC and analytical activities, ensuring GMP compliance across method transfer, validation and laboratory operations. The successful candidate will lead investigations, audits and QMS improvements, while partnering closely with QC, MSAT, Manufacturing and Regulatory Affairs to keep BioOra's quality systems inspection-ready and aligned with regulatory and commercial goals. Key responsibilities will include: 

• Provide QA oversight of QC and analytical activities in line with GMP and regulatory requirements
• Lead QA activities for analytical method transfer, qualification and validation
• Review and approve QC documentation, including specifications, validations, deviations and CAPAs
• Oversee OOS/OOT investigations, ensuring robust root cause analysis and corrective actions
• Lead internal audits of QC laboratory operations and support external/regulatory audits
• Maintain and improve QMS processes, including change control, risk management and inspection readiness
• Analyse quality metrics to identify trends and drive continuous improvement
• Partner cross-functionally with QC, MSAT, Manufacturing and Regulatory Affairs

What do you bring to the role? 
Bring your relevant tertiary qualification in a scientific field, along with previous experience in a GMP environment, and a solid understanding of Quality System processes and cGMP regulations. Your skill at communicating technical information clearly and concisely, highly organised with strong attention to detail, and comfortable thinking on your feet to make quick, informed decisions will be key to success in this role. It would be an advantage to have a background in pharmaceutical or a similar industry. 
You will have: 

• A relevant qualification in a scientific field
• Have a sound knowledge of Quality System processes and familiarity with GMP environments
• Ability to clearly and concisely communicate technical information.
• A proactive and solutions focused mindset.
• Impeccable at attention to detail, with sharp organisational skills.
• Ability to think on your feet, and make quick, informed decisions.

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!

This role is based in Wellington, however this year we are building our new state of the art facility in Christchurch, so if you are keen for a move to a new city in 2027, this is also possibility. 
 
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 once our humans will assess fit across the organisation.

We'll also be checking you've answered the following question: What is your go to drink to get you up in the morning - tea, coffee, or something else and why? 
Applications close Sunday 6th September 2026
 
We will be reviewing applications as they come in. We encourage early applications as the advert may close early. 
*****Please note, to be considered for this role you MUST already have the legal right to work in New Zealand.