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Women in Nuclear: a conversation with Eden Carnegie on Quality Assurance

Posted on: 29 November 2021Company,Latest News

Cyclotek’s Media Associate Nicoletta Snellen recently sat down with Eden Carnegie, Quality Assurance Associate at Cyclotek, to talk about her professional journey in nuclear medicine. Cyclotek recently announced a partnership with Women in Nuclear Australia, with the aim to promote education, awareness and gender diversity within the nuclear industry.

 

Can you tell us a little bit about your background in nuclear medicine, what’s your story?
I’ve been working in the nuclear medicine sector for about 9 years now, starting off at Global Medical Solutions (GMS) as a Production Radiochemist, then entering Cyclotek as a Production/QC Chemist, eventually moving on to my current role as Quality Assurance Associate at Cyclotek’s Queensland facility.

 

It seems like you’ve had a lot of professional development at Cyclotek, can you tell us about your journey from studying Forensic Chemistry, to working at GMS, and then now to working at Cyclotek. 
At university, I completed a double Bachelor’s degree in Forensic Chemistry and Criminology/Criminal Justice, however I was definitely more interested in the forensic science side of things. Throughout my degree, I knew that I was probably going to go towards a science discipline, but I never expected I would end up in Nuclear Medicine.

What I found most intriguing about the role with GMS was the radiation side of things. Before entering this field, I actually wasn’t even aware that we had a reactor in Australia! So, when I started at GMS, I had no idea what to expect, but I adapted pretty quickly to my role as Production Radiochemist and the night shifts.

What I’ve found from joining Cyclotek is that you come to know your self-worth as a professional a lot more than in other workplace settings. Moving to Cyclotek was like moving from a small pond to a much bigger ocean, with much larger scale product delivery and customer supply. I actually learnt a lot more in my first 6 months of training at Cyclotek than I did in my entire previous working history!

 

What was it that inspired you to join Cyclotek?
I started at Cyclotek in 2015, when Cyclotek’s Queensland facility (CQPL) was still being built. My first interview with Greg Santamaria, was at a café, because the CQPL building wasn’t even finished yet. We still occasionally go to that cafe – it’s called Catalyst, so it’s even got a scientific name!

I was so excited to join, because how often do you actually get to be a part of building a company from scratch? For me, to have that opportunity in a field I was already interested in, was one I could not pass up. Even though I knew very little about Cyclotek at the time, I knew that I had to learn more!

I’ve really enjoyed being a part of building our systems and procedures here at Cyclotek. From the initial start-up phase to now, we have evolved all of our procedures in line with our philosophy of continuous development. We document even the smallest corrective measures along the journey, which ensures new staff have the best chance in delivering quality product that the industry has come to expect from us.

 

Can you tell us about a typical day as a Production Chemist?
A typical production night when I was working as Production Chemist would start with facility start-up, equipment checks, checking customer orders, reviewing of the manufacture schedule and checking on the cyclotron. The whole set-up process is quite simple actually, as we have a robust checklist in front of us and if everything is green lights, we’re ready to go! If ever needed, we also have access to on-call engineering support.

Once everything is ready to go, we can power up the cyclotron and beam for the duration required to meet our customers’ needs. From there, we prepare all the instruments and consumables required in that evening’s production, which includes: sanitising the grade C hotcells, setup of the synthesiser including pre-synthesis checks, and preparing of the specific re-agent kits and cassettes. Environmental monitoring is also undertaken on a per batch basis. Once preparation activities are completed and the cyclotron has produced the required activity for the customer orders, we’re ready to begin synthesis. We operate in two-person teams during production and you really need to trust one another to complete the work to a high standard. Dispensing of the product into each customer’s vial requires the team to coordinate the manual process of dose fractionation, with the second operator calculating and confirming dose requirements, as well as recording in our batch records each customer’s final activity dispensed in the vial. Come dispensing time, one person will be on the computer informing the other staff member at the dispensing cell how much product is needed for each customer order.

Working in production, you have to be adaptable and always ready for a change of plan. Various aspects of scheduling and logistics could change at any moment, with aircraft times frequently changing, late additions of customer doses, a lower-than-planned synthesis yield or the call for support from another cyclotron operator, including those in our own network in NSW and VIC; no week is ever the same for us!

 

Can you tell us a little bit more about what it’s like operating a medical cyclotron?
It’s a little daunting when you first start, but the environment of the cyclotron is so controlled that there is very little you can do wrong. Having the training, knowing what you’re doing and being alert on night shift is so important. The thing about radiation within our facility is that as long as you’re aware of it, you’re safe. We have extensive monitoring devices, equipment and training in place at Cyclotek, so you’ve got everything at your fingertips to keep yourself aware and safe. It’s very exciting to be honest because nuclear medicine can do so much good!

Operating the cyclotron is really cool, it’s a huge machine and although it’s only one component of what we do, it’s probably the most important. Managing the medical cyclotron is very strange to me because you go through this whole big process, operating this giant particle accelerator and your final product from the cyclotron is this tiny volume—at around 5mL—but that small amount can have an enormous impact on more than one hundred patients on any given day.

 

I understand that you’re also Cyclotek QLD’s Radiation Safety Officer, can you tell me what the role requires?
I was interested in the role as I like to be aware of my surroundings and thought this would add to my value at Cyclotek and its staff. With the radiation and chemical hazards in our industry, safety always has to be the first thought.

On a regular basis, I review the daily reports from staff Electronic Personal Dosimeter (EPD) badges to ensure alignment with our dose constraints—which are well within Australia’s legal limits—together with ensuring the 4-week data for our extremity badges are reviewed and provided to our staff.  Managing variances in these results, requires assessment as to staff tasking and activities required for production. In some cases, action may need to be taken to ensure staff don’t exceed our internal constraints. As we operate a multidisciplined team, with many of us trained to work in production, quality control testing and logistics, where necessary, ensuring staff remain within their respective constraints is important to maintaining our output.

My role as RSO also ensures that procedures relating to accessing high radiation fields are attended to, taking into account safety, tasking and time. Over the years we have developed good skills in managing the theoretical dose and the actual dose of such activities. This is an important aspect of managing and running a successful cyclotron facility.

Cyclotek has an extensive Radiation Management Plan (RMP), which I review annually for any necessary updates. Recently, we have embarked upon a radiation footprint for our facilities to better understand radiation emission and process characteristics across different times in the facility. We hope this data will provide for better operational awareness and provide insight into any weaknesses, vulnerabilities or variabilities we should be aware of. This method of reporting is still very new, but will eventually be rolled out at each site for assessment and for comparative purposes.

 

Moving on to your role now as Quality Assurance Associate, what does that entail? Was there a moment where you knew you were going to be working in this space?
Quality Assurance is mostly about site compliance, maintaining good manufacturing practice and ensuring that there is quality in each product we manufacture. My job extends from simple day-to-day tasks like environmental monitoring or reviewing batch records to investigations. However, recently I’ve been getting involved in many corporate level projects that range across the Cyclotek group, such as helping to develop and improve our product quality systems. At CQPL, I get to work with another Quality Assurance Associate, Lachlan Klein. It’s a great role, because as we’ve grown as a company, our need for greater quality oversight has also increased. Often there are new aspects to assess, validate and qualify, and as a result we’re reaching more patients than ever!

There wasn’t actually a specific moment for me when I knew I would be working in Quality Assurance, I sort of fell into the role (but quite gladly). At Cyclotek, there is always a focus on quality assurance in everything we do. QA doesn’t only extend to the final product; it’s built-in from the very beginning of facility design. Just through my work in production and quality control, I realised that there were aspects of QA that were already in my mind and my interest grew from there. To answer your question, it’s hard to pinpoint the moment that it happened for me, because I think my interest in QA was piqued from the very beginning!

 

Why is quality assurance so important to our work at Cyclotek?
All the work that we do at Cyclotek is so important as it contributes to improving patient outcomes. When we think about how important the products that we manufacture are to patients, we need to ensure we are building quality into every aspect of what we do; that’s why quality assurance is so important. We need to guarantee not just to our customers, but most importantly, to their patients, that what we’re producing is exactly what we’re saying it is, because the impact is so critical. As I said earlier, quality assurance is built into every aspect of our procedures and that allows us to continue manufacturing high-quality products for patients in need every single day.

 

What is it about the work that we do at Cyclotek – or perhaps more broadly in nuclear medicine – that inspires you?
For me, it’s the fact that the work we do every day impacts patient outcomes and that is important. To come into CQPL, knowing that the work I and my co-workers are doing is important, is pretty inspiring!

For example, we recently completed product development of 18F-FBB into our New Zealand facility. This was so impactful for us as COVID had seriously impeded our ability to ship 18F-FBB into Auckland and Christchurch. Pivoting the whole Cyclotek group into the validation of this product, without any support from the usual product development team on site at New Zealand required a multidisciplined and talented team, with Marc Couperthwaite and I taking a lead role in bringing this capability into another country. It was an extremely exciting and rewarding experience! Opportunities like this exist at Cyclotek because as the product range is expanding, patients, physicians and researchers are seeking it out.

 

Absolutely, I’ve learnt from many of my conversations with the Production and QA teams at Cyclotek, that managing short-lived products with frequent flight delays is no easy feat­ – do you have any advice for how you remain optimistic and keep on your toes?
This work is definitely not for the feint hearted. I think you have to care a lot about our work to be in this industry. It can be so disheartening when you go to so much effort only to find out the product couldn’t reach the patient; but if you care enough, you know that it is worth trying again, and it’s so rewarding when you know that your work has made an impact in someone’s life.

 

What is your advice for other women who are looking to develop themselves professionally, but might not know where to begin?
I would say look to your role models – and your role models don’t have to be other women, you might find role models in your brothers, fathers or male friends. Your role model might not even be in the same industry as you, but if there are aspects of them that you admire and you want to emulate, it will help you professionally and may give you some ideas of where you find your own strengths or where you see yourself going.

My Nanna, who has unfortunately passed on, has always been a great role model for me, as well as my own mother. Nanna was a housewife, but she definitely had the brains to study and I think she always wished she had studied; she often said she felt like she got to study through my mother and I by asking us “what did you learn today?”.

My mum has also been a great role model for me, she’s now an accountant but she’s had a huge amount of role diversity in her career, all whilst being a single mum. Growing up watching her work and study so hard, whilst always making time for us and our family, has been really inspiring for me.

 

Do you have any final words of advice for other girls and women who might be thinking about a career in STEM industries?
For me, it’s all about learning everything you can, you meet so many interesting people in your job setting that you can learn from. You might start in one industry and end up somewhere completely different. I studied forensic science at university, so I definitely did not see myself in nuclear medicine to begin with. From Cyclotek I’ve learnt so much that has brought me to my current roles as Radiation Safety Officer and Quality Assurance Associate.

 

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