QC Microbiology Analyst — Cleanroom & GMP Specialist

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

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.