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Open nowPosted 46 hours ago

QC Analyst - Microbiology

Arbetsförmedlingen (Platsbanken)39,552 open roles

Where
Göteborg, Västra Götalands län, Sweden
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Your applicationOpen nowQC Analyst - MicrobiologyArbetsförmedlingen (Platsbanken) · Göteborg, Västra Götalands län, Sweden

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This job: posted 46 hours ago

The posting

At CCRM Nordic, we are accelerating the development and commercialization of advanced therapies that have the potential to transform patients' lives. Our GMP facility and expert teams support the development and manufacturing of cell and gene therapy products, helping bring innovative treatments closer to the people who need them. We are now looking for a QC Analyst Microbiology to join our Quality Control (QC) team at GoCo Health Innovation City. This is an exciting opportunity for someone with a strong microbiology background who thrives in a GMP-regulated environment and enjoys combining hands-on laboratory work with data review, investigations, and continuous improvement. The role As QC Analyst you will make sure our cleanroom environments and manufacturing operations meet GMP standards. You will run cleanroom environmental monitoring and sterility-related QC activities, help keep contamination control robust, and be the team's go-to person (subject matter expert) for microbiology. You will work closely with manufacturing during aseptic processing, contribute to investigations and continuous improvement, and give technical support to your QC colleagues. Key responsibilities Carry out cleanroom environmental monitoring (EM): viable, non-viable, surface and personnel monitoring

Sample according to approved SOPs, EM plans and GMP requirements

Monitor cleanroom conditions during manufacturing to support aseptic processing

Incubate samples, read plates, count colonies and identify microorganisms

Review and trend EM data, and flag adverse trends early

Investigate EM excursions and contribute to deviations, root cause analyses and CAPAs

Report and escalate EM results on time

Perform sterility, endotoxin and mycoplasma testing

Perform QC testing of viral vectors and cell-based assays

Write and review SOPs, EM programmes and quality documentation

Act as a microbiology subject matter expert within the QC team

Required qualifications Master's degree or PhD in Microbiology or a related discipline

At least 1 year of hands-on experience with cleanroom environmental monitoring

Solid knowledge of cleanroom behaviour and gowning procedures.

Hands-on experience with cell culture, cell-based assays and microbiological testing

Fluent professional English, written and spoken

Preferred qualifications Experience working with a sterility isolator

Experience with molecular biology techniques

Experience with viral vector testing (AAV, lentivirus)

Experience from an ATMP or CDMO organisation

Who you are You care about quality and pay close attention to detail, while staying flexible in a growing organisation. You take ownership, share what you know and like improving how things are done. Why CCRM Nordic? CCRM Nordic is on an exciting growth journey, and this is an opportunity to be part of building something truly unique. We offer a dynamic and collaborative environment where talented people come together to solve complex challenges and contribute to the advancement of cell and gene therapies. Here, your expertise and ideas matter. You'll work alongside passionate colleagues, gain exposure to cutting-edge technologies, and have the opportunity to grow both professionally and personally while helping us shape the future of advanced therapy manufacturing. Apply today! Send in your application today. We review applications on an ongoing basis and look forward to hearing from you!

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