QC Analyst - Microbiology

CCRM Nordic AB; Mölndals kommun; On-site; SEK 520,000 - 700,000; Full time

Job summary

CCRM Nordic AB is seeking a QC Analyst Microbiology to join our Quality Control team at GoCo Health Innovation City. You will perform cleanroom environmental monitoring, sterility, endotoxin, and mycoplasma testing, while supporting aseptic processing and data review.

You should have a strong microbiology background, hands-on GMP experience, and fluency in English. The role combines lab work with investigations, CAPAs, and SOP development to strengthen contamination control and product quality.

Qualifications

• Master's 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.

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.

Skills

Microbiology

Cleanroom monitoring

Cell culture

GMP environment

English proficiency

Education

Master's or PhD in Microbiology

Tools

Molecular biology techniques

Sterility isolator

Viral vector testing (AAV, lentivirus)

Cell-based assays

Job description

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.