QC Analyst – Biopharma Chemistry & Microbiology

Alexion Pharma Spain S.L.; Athlone; Remote; EUR 60,000 - 80,000; Full time

Job summary

Alexion Pharma Spain S.L. in Athlone, Ireland is seeking a QC Analyst to support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture.

The role includes method validation, lab safety, and reporting responsibilities. The ideal candidate holds a BSc in biosciences with 3 years of QC lab experience, knowledge of cGMP, and strong technical writing skills.

Qualifications

• BSc (Hons) in biosciences and 3 years’ experience.
• Working knowledge of cGMP in QC lab environment.
• Ability to follow SOPs, record work accurately, and pay close attention to detail.
• Able to perform routine tasks with minimal supervision.
• Strong lab safety awareness and risk mitigation.
• Strong technical writing and report writing skills.
• Experience with gLIMs is preferred.

Responsibilities

• Perform analytical testing and environmental monitoring sampling for all cleanroom facilities.
• Validate/qualify microbiology and chemistry test methods and testing systems.
• Investigate out-of-spec results using root-cause analysis and implement corrective actions.
• Represent QC in internal and external audits and close out actions.
• Provide technical review of data, protocols and reports; support manufacturing.
• Coordinate training and ensure qualifications are up to date.
• Order and stock laboratory supplies; provide lab support and equipment maintenance.
• Prepare monthly and quarterly environmental monitoring trend reports.

Skills

Analytical testing

Environmental monitoring

Technical writing

cGMP knowledge

SOP adherence

Education

BSc (Hons) in biosciences

Tools

HPLC

UV

gLIMs

SOPs

Job description

Alexion Pharma Spain S.L. in Athlone, Ireland is seeking a QC Analyst to support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture.

The role includes method validation, lab safety, and reporting responsibilities. The ideal candidate holds a BSc in biosciences with 3 years of QC lab experience, knowledge of cGMP, and strong technical writing skills.