Microbiology QC Analyst – Cleanroom & GMP

Ccrm-Nordic-Ab-; Göteborgs kommun; On-site; SEK 600,000 - 750,000; Full time

Job summary

CCRM Nordic is seeking a QC Analyst Microbiology to join our QC team at GoCo Health Innovation City. The role focuses on ensuring cleanroom environments and manufacturing operations meet GMP standards, with hands-on microbiology work and data review.

You will run environmental monitoring, support aseptic processing, and contribute to investigations and continuous improvement while collaborating closely with manufacturing and QC colleagues.

Qualifications

• Master's degree or PhD in Microbiology or 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: 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 elevate 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

GMP

Data review

Investigations

Continuous improvement

English proficiency

Education

Master's degree or PhD in Microbiology

Job description

CCRM Nordic is seeking a QC Analyst Microbiology to join our QC team at GoCo Health Innovation City. The role focuses on ensuring cleanroom environments and manufacturing operations meet GMP standards, with hands-on microbiology work and data review.

You will run environmental monitoring, support aseptic processing, and contribute to investigations and continuous improvement while collaborating closely with manufacturing and QC colleagues.