Overview
The QC Batch Release / Chemistry Support Analyst will support the QC department with emphasis on QC review and EM batch release.
The QC Batch Release / Chemistry Support Analyst will also support Chemistry product testing for Drug Product and Drug Substance manufacture at Alexion Athlone.
The QC analyst will also provide technical support with regard to testing and review.
The QC analyst will be an SME on product testing and will participate in training and investigations as needed.
Responsibilities
Perform technical review of data generated in laboratory, validation protocols and reports.
Perform technical review of data generated during Environmental Monitoring.
Facilitate laboratory investigations and support associated product investigations.
Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
Support the QC department in internal and external audits where appropriate.
Maintain competence and keep up to date with all new technologies, procedures and methods used in the QC Laboratories.
Perform chemistry product testing for Drug Product and Drug Substance manufactured at Alexion Athlone.
Minimum Qualifications
Minimum of 5 years of experience in a cGMP Quality environment.
Working knowledge of cGMP in a QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis.
Ability to understand and follow written SOPs, accurately and legibly record work in real time, and pay close attention to detail.
Ability to perform routine tasks with a minimum of supervision.
Strong technical writing and report writing skills.
Experience in the use of gLIMs.
Preferred Qualifications
Familiarity with continuous improvement methodologies such as Six Sigma or Lean.
Experience working in a global and diverse work environment.
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