Quality Control Specialist Microbiology & Compliance

Summary

This role is primarily on-site, with approximately 80% of working time spent on-site and 20% working from home, subject to agreement. The position is offered as a temporary contract, with the possibility of extension or conversion to a permanent role. Weekend work may be required as part of a team-based rotation.

Relocation support is not available for this role, so applicants should apply only if the location is accessible.

The QC Specialist Microbiology & Compliance acts as Point of Contact and Subject Matter Expert (SME) for QC compliance, environmental monitoring (EM), aseptic and cleanroom practices at the site. The role ensures compliant, consistent and efficient microbiological and QC operations in support of batch release, contamination control strategy, and regulatory requirements. The role contributes to the quality control processes, acting as backup to provide operational support in QC release testing (product and materials) as needed.

About the Role

Key Responsibilities

• Own and govern the site Environmental Monitoring (EM) program (cleanrooms, utilities, personnel).
• Perform trending and signal detection, define alert/action limits and ensure alignment with contamination control strategy.
• Act as primary trainer/qualifier for aseptic techniques and microbiological practices, and standardise training content across teams and shifts.
• Lead continuous improvement of EM and aseptic processes and methods.
• Ensure timely escalation of adverse trends and impact on product quality.
• Own and lead investigations related to laboratory, microbiological and aseptic events.
• Ensure compliance with GMP, Annex 1, contamination control expectations and act as SME during audits and inspections.
• Support change controls, risk assessments, and quality impact evaluations.
• Perform deviation trending, recurring deviations assessments to enhance and maintain compliance levels of the QC team.
• Act as TMS-C.
• Act as backup to provide operational support in QC release testing (product and materials) as needed. Ensure testing continuity during weekends, absences, or peak demand.

Essential Requirements

• Bachelor’s or Master’s Degree in Microbiology, Biology or related field.
• 3+ years of experience in pharmaceutical QC laboratory, aseptic environments or company equivalent in a strongly regulated environment.
• Experience with Environmental Monitoring and cleanroom classification.
• Excellent knowledge of good laboratory practices and cGMP.
• Familiarity with GMP and Annex 1 requirements is highly desirable.
• Experience or knowledge on radiopharmaceutical environments is recommended.
• Open and clear collaboration and communication with third parties.
• Fluent Dutch and English, written and spoken.

Desirable Requirements

• Experience in a radiopharmaceutical, biotech, or analytical laboratory environment is preferred.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of the team go far beyond base pay and incentives. Benefits include competitive insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, flexible and hybrid working options may be available where possible, along with a minimum of 14 weeks paid parental leave.

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.