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 halfway through phase two of clinical trials, we need a Senior QA Associate to keep help us across the line. You'll take a lead role in developing and monitoring our QMS, ensuring strict adherence to quality and regulatory standards. Taking ownership of designated QMS workflows you'll ensure we are on track to meet deadlines. Your expertise will set the standard in upholding our commitment to the highest standards and quality in our operations. This encompasses: 

• Acting as a conduit between the Quality Manager and QA Associates.
• Reviewing high-level documentation as well as carrying out document control activities.
• Oversight of the batch records documentation and batch release process as required.
• Maintaining and improving existing quality processes to ensure continuously appropriate/compliant operation of 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.
• Risk assessments related to processes, equipment, and product quality.
• Data analyses and reporting internally on trends/metrics.
• Carrying out PQRs (product quality reviews) as required.

What do you bring to the role? 

Coming from a GMP environment, you'll have at least four years' experience in a similar role, coupled with a relevant scientific degree. A strong preference will be given to a background in pharmaceuticals / biotech. Additionally, you will have: 

• An excellent working knowledge of Quality System processes and relevant cGMP regulations.
• A strong interest in compliance within the pharmaceutical, biotechnology, or medical device industries.
• The ability to clearly and concisely communicate technical information.
• A proactive and resourceful 'go getter' attitude
• An outcome focus and drive to achieve goals that benefit the whole.
• Impeccable at attention to detail, with sharp organisational skills.
• The ability to think on your feet, and make quick, informed decisions.
• Strong people skills as someone who leads by example.

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

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.  

When you apply 

We love AI, but not when it comes to human beings applying to work for us.  We don't want to know what AI says about you, we want to hear what you say about you, so no AI cover letters please.  

Also, as a little test to check you've fully read the ad, if you haven't answered the following question, we will not be taking your application further: "In the video on our website that explores our facilities, what colour masks are our team wearing?"  

If you see more than one role advertised, please only apply once. We're a small hiring team and will consider applications across BioOra so don't worry, you won't miss out on other roles if we see a better fit.  

*Please note, to be considered for this role you MUST already have the legal right to work in New Zealand.