Quality Control Specialist, Carlow

About the Company Our client is a globally recognised pharmaceutical company focused on delivering innovative healthcare solutions and maintaining the highest quality standards.

We are currently seeking a motivated

Quality Control Specialist

to join a high-performing QC Microbiology team within a regulated pharmaceutical manufacturing environment.

The successful candidate will support QC Microbiology operations, ensuring compliance with

GMP , regulatory requirements, and company quality standards while driving continuous improvement initiatives.

Key Responsibilities

Support the

Environmental Monitoring Program

through data trending, analysis, and implementation of

Corrective and Preventative Actions (CAPA) .

Own and support

Environmental Monitoring Risk Assessments

and qualification activities.

Generate

Quarterly

and

Annual Trend Reports

for microbiology operations.

Develop and execute

Microbiology Test Methods

and

Validation Studies .

Troubleshoot issues arising during

Routine Testing

and validation activities.

Provide microbiology support for

Site Investigations , environmental monitoring, and utilities monitoring projects.

Drive

Continuous Improvement

initiatives including

Lean Lab Projects

and method optimization.

Author and manage

SOPs ,

Change Controls ,

Deviations , and controlled documentation in line with

GMP

requirements.

Review and authorize microbiological results to support

Batch Release

activities.

Ensure compliance with

Regulatory Requirements ,

ALCOA(+) Data Integrity Principles , and company

Quality Standards .

Requirements

Bachelor’s Degree

in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences field.

Minimum

3 Years’ Experience

in a

GMP QC Microbiology Laboratory .

Strong knowledge of

Environmental Monitoring ,

Aseptic Processing , and

Contamination Control .

Experience with

Trending ,

Risk Assessments ,

Validation Studies , and

Data Analysis .

Ability to author

SOPs ,

Change Controls ,

Deviations , and quality documentation.

Familiarity with

Regulatory Requirements ,

ALCOA(+) Data Integrity , and electronic laboratory systems.

Contract Details This opportunity is an 11-month contract, on-site in Carlow.

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