QA Validations Specialist

Who is BioOra?

BioOra is the first approved Chimeric Antigen Receptor (CAR) T-cell commercial manufacturing company in New Zealand. 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.  With a focus on innovation, scalability, and accessibility, we are poised to transform the way CAR T-cell therapies are delivered, bringing hope and healing to patients on a global scale

What will you do?

Based in Christchurch, your role will be critical in ensuring our equipment, facilities and test methods uphold the highest quality and regulatory compliance standards. Reporting to our Head of Quality you will support our growth objectives in alignment with GMP regulations, internal SOP's and international standards. You'll work with internal team members, customers and suppliers to verify that validation and qualification is accurate and on time. To achieve this, you will:

• Review and approve URSs, qualification, and validation plans, and document DQ, IQ, OQ, and PQ phases.
• Conduct risk assessments, review commissioning protocols and reports.
• Ensure requirements traceability across the full validation lifecycle.
• Manage validation lifecycle documentation.
• Conduct validation impact assessments prior to implementing changes.
• Perform routine assessments of GxP-verified services.
• Manage validation deviations and support CAPA investigations with thorough documentation and follow-up.
• Contribute to continuous improvement initiatives.
• Promote adherence to cGMP in all validation-related activities.

What do you bring to the role?

With the volume of experiments and paperwork required from the get-go, it's essential you are BSc qualified, with at least three years' experience supporting or leading validation activities. As this is a new role, you'll have comprehensive knowledge of validation methodologies and quality systems including compliance with Medsafe, TGA and international cGMP/GDP standards. In addition will be:

• A strong understanding of manufacturing processes within regulated environments.
• Exceptional analytical and problem-solving skills with strong attention to detail.
• The ability to simplify complex issues into clear, actionable tasks for colleagues.
• Demonstrated independence in managing projects and completing tasks effectively.
• Outcome focused with the drive to achieve goals that benefit the whole.
• Exceptional analytical and problem-solving skills with impeccable at attention to detail.
• The 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

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.