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Job Description

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
Bachelors 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

Salary Range