Role Overview
The Quality Control Microbiology Analyst is responsible for supporting laboratory operations within the Quality Control department by performing microbiological testing, maintaining laboratory systems, and ensuring compliance with Good Manufacturing Practice (GMP) requirements.
This role works collaboratively with cross-functional departments to ensure quality control testing activities are completed accurately, efficiently, and in accordance with regulatory standards. The successful candidate will be an experienced professional with a strong background in pharmaceutical microbiology and quality compliance.
Key Responsibilities
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Perform microbiological testing and laboratory activities in compliance with GMP and site procedures.
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Support QC material release processes and assist with laboratory testing schedules to ensure timely product disposition.
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Participate in laboratory equipment qualification, maintenance, and utilities monitoring as required.
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Execute laboratory testing procedures and ensure all documentation is completed accurately and in compliance with regulatory standards.
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Review and support approval of QC documentation, test records, and laboratory reports.
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Contribute to departmental Key Performance Indicators (KPIs) and support delivery of laboratory goals and continuous improvement initiatives.
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Participate in cross-functional site teams and collaborate with other departments to support operational objectives.
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Maintain and expand knowledge of microbiological methods, laboratory technologies, and evolving regulatory requirements.
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Support internal and external audits and assist with the preparation of audit documentation where required.
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Ensure compliance with Environmental Health and Safety (EHS) policies and promote safe laboratory practices.
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Actively contribute to a culture of quality, safety, and regulatory compliance across the site.
Skills and Competencies
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Ability to build and maintain effective working relationships across teams and departments.
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Strong teamwork and collaboration skills.
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High level of accountability for accurate and compliant execution of laboratory tasks.
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Clear and professional written and verbal communication skills.
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Problem-solving mindset with a focus on continuous improvement.
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Demonstrates integrity and commitment to quality and compliance standards.
Education and Experience
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Bachelor's degree (or equivalent) in Microbiology, Pharmaceutical Science, or a related scientific discipline.
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Minimum of 3 years' experience in a Quality Control Microbiology role within the pharmaceutical industry, with 5+ years preferred.
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Demonstrated experience working in a GMP-regulated laboratory environment.
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Broad professional experience contributing to laboratory operations, testing programmes, and quality systems.
