Job Description: QC Microbiology Deviation Specialist (level 5)

Department: Quality Control – Microbiology
Reports To: QC Microbiology Manager / QC Supervisor

Position Summary:

The QC Microbiology Deviation Specialist provides technical and quality systems support for Environmental Monitoring (EM) investigations, Event Records (EVs), deviations, and associated CAPAs within the QC Microbiology function. The role is responsible for ensuring microbiological data are accurately assessed, investigations are supported with scientifically sound information, and quality records are completed in accordance with GMP requirements and site procedures.

The specialist acts as a key contributor to contamination control, deviation management, and continuous improvement activities while supporting inspection readiness and compliance objectives.

Key Responsibilities:

Environmental Monitoring Investigation Support
• Support Environmental Monitoring investigations by providing microbiological expertise and technical assessment of EM data.
• Review environmental monitoring results associated with investigation activities.
• Compile and analyse investigation data to support root cause determination.
• Perform microbial identification data reviews and support interpretation of results.
• Assist in assessing potential product, process, and facility impact resulting from EM events.
• Collaborate with cross-functional teams to support timely closure of EM investigations.

Quality Event Management
• Initiate and support Event Records (EVs), deviations, and quality investigations related to environmental monitoring and microbiological testing activities.
• Ensure quality records are completed accurately and within established timelines.
• Prepare supporting documentation, technical assessments, and investigation summaries.
• Support investigation teams by providing microbiological expertise and quality system knowledge.
• Partner with Quality Assurance to ensure compliance with site procedures and GMP requirements.

CAPA Management
• Support the development, implementation, and closure of Corrective and Preventive Actions (CAPAs).
• Track CAPA actions to completion and ensure required documentation is maintained.
• Participate in effectiveness checks and follow-up activities as required.
• Support identification and implementation of process improvements arising from investigation outcomes.

Compliance and Continuous Improvement
• Ensure compliance with GMP requirements, site procedures, and data integrity standards.
• Support internal audits, regulatory inspections, and inspection readiness activities.
• Participate in continuous improvement initiatives related to contamination control and quality systems.
• Contribute to the creation, revision, and maintenance of procedures, work instructions, and training materials.
• Promote a culture of quality and compliance within the QC Microbiology function.

Qualifications

Education
• Bachelor's degree in Microbiology, Biological Sciences, Biotechnology, or related scientific discipline.

Experience
• 3-5 years of experience within a GMP-regulated pharmaceutical or biotechnology environment.
• Experience working in a QC Microbiology laboratory.
• Experience with Environmental Monitoring programs and quality systems.
• Familiarity with deviations, Event Records, CAPAs, and GMP documentation practices.

Technical Knowledge
• Environmental Monitoring programs
• Cleanroom contamination control principles
• Microbial identification techniques
• GMP regulations and quality systems
• Data Integrity (ALCOA+)
• Root Cause Analysis principles
• Risk Assessment methodologies
• EU GMP Annex 1 requirements

Key Competencies
• Strong attention to detail
• Technical writing and documentation skills
• Effective cross-functional collaboration
• Organizational and prioritization skills
• Ability to manage multiple quality records simultaneously
• Strong understanding of contamination control and microbiological risk

Key Performance Indicators
• On-time completion of EVs and supporting investigation activities
• CAPA action completion within target timelines
• Accuracy and quality of investigation documentation
• Audit and inspection readiness
• Effectiveness of CAPA implementation and closure