QC Analyst: Chemistry & Microbiology Lab

Alexion-Pharmaceuticals-; Athlone; On-site; EUR 40,000 - 55,000; Full time

Job summary

Alexion Athlone is seeking a QC Analyst to support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture. The role also provides technical support for facility testing oversight, test method validation, and introduction of new technology to the laboratory.

The QC analyst will be an SME on product testing and environmental monitoring with responsibility for investigations and report writing, audits, and continuous improvement

Qualifications

• Requires a BSc (Hons) in biosciences and 3 years of QC experience.
• Working knowledge of cGMP in a QC lab environment.
• Ability to follow SOPs, record work accurately and pay attention to detail.
• Ability to perform routine tasks with minimal supervision.
• Strong lab safety understanding and risk mitigation abilities.
• Strong technical writing and report writing skills.
• Experience with gLIMS.

Responsibilities

• Perform analytical testing and environmental monitoring sampling and testing for all cleanroom facilities.
• Maintain high cGMP and GLP standards during testing with right first time approach.
• Ensure safety requirements in the lab are adhered to.
• Adhere to schedules and targets to meet regulatory and business needs.
• Validate/qualify microbiology and chemistry methods and testing systems; generate reports.
• Represent QC in audits and close out actions.
• Perform technical review of data, validation protocols and reports; support Manufacturing and Projects.
• Identify and implement continuous improvement within the QC lab.
• Investigate out-of-spec results with Root Cause Analysis and corrective actions.
• Order, stock and receive laboratory supplies.
• Provide lab support including reagent prep, cleaning and equipment maintenance.
• Ensure training is up-to-date and support colleague training.
• Manage samples for testing and authorize results.
• Support QC activities like shipments, CoA review and material release.
• Prepare monthly and quarterly Environmental Monitoring trends and annual reports.
• Coordinate alert/action excursions for QC.

Skills

3 years' experience

cGMP knowledge

SOPs understanding

Lab safety awareness

Technical writing

gLIMS experience

Chemistry & Microbiology testing

Education

BSc (Hons) in biosciences

Tools

HPLC

UV

gLIMS

Job description

Alexion Athlone is seeking a QC Analyst to support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture. The role also provides technical support for facility testing oversight, test method validation, and introduction of new technology to the laboratory.

The QC analyst will be an SME on product testing and environmental monitoring with responsibility for investigations and report writing, audits, and continuous improvement