QC Bioanalytical Professional

3 days ago

Dublin, Dublin City, Ireland beBeeBioanalytical Full time

Our ideal candidate will be a skilled bioanalytical professional with expertise in laboratory testing and technical writing.

Job Description

The successful applicant will join our team as a QC Bioanalytical Specialist, leading laboratory investigations and serving as a subject matter expert for change controls on site. Strong communication skills are essential for collaboration with different departments and working on various projects.

Key Responsibilities
  • Lead technical Laboratory Incidents, Investigations, and Problem Solving
  • Support routine analytical testing with assays such as HPLC, CE, UV, Compendial, PCR, and ELISA techniques on Release, In-process, Raw Materials, and Stability samples
  • Lead local change controls and participate as a laboratory SME for changes in the network that impact the laboratory
  • Author, Review, and Approve technical writing activities such as Protocols, Reports, and procedures
  • Participate and lead Continuous Improvement and Laboratory Transformation projects
  • Support Divisional, Regulatory, and EHS audits as an SME in your area on site
  • Play a key role in the troubleshooting and escalation process on site
  • Calibrate and maintain all designated laboratory instruments
Requirements
  • Bachelor's degree (or higher) in Natural Science/Chemical Engineering/Biological Engineering
  • Minimum 4-7 years' experience in the pharmaceutical industry
  • Experience in performing Laboratory testing with a good understanding of relevant Analytical techniques
  • Experience in Technical writing (Investigations, Procedures, Change Controls etc.)
  • Project participation and leading experience
  • Experience in participating in audits as an SME (Subject Matter Expert)
  • Working knowledge of Six Sigma and Lean methodologies
  • Knowledge of GMP practices
  • Working knowledge of ICH guidelines and global pharmacopeial requirements
Benefits

This is a great opportunity to work in a dynamic environment with talented professionals who share a passion for innovation and improving healthcare outcomes.

How to Apply

If you have the necessary skills and experience, please submit your application through our official channels.

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