LSC has a great contract opportunity for a QC Bioassay Analyst to join a global Biopharmaceutical company.
This state-of-the-art vaccines and biologics manufacturing facility currently produces products in various therapeutic areas, including oncology, autoimmunity, pneumonia, and infectious disease.
About the Project
Key Responsibilities:
* Ensure timely completion of all assigned data processing and reviewing.
* Complete Laboratory Investigation Reports and deviations through site procedures.
* Generate trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
* Communicate testing progress, deviations etc. during QC Tier 1 daily meetings.
* Peer review testing documentation and ensure data integrity compliance and QC Right First Time KPIs are achieved.
* Review, approve and trend test results where applicable.
* Participate in laboratory aspects of OOS investigations.
About You
Are Your Skills a Match?
* Minimum 2+ years of experience in a cGMP laboratory environment.
* Bachelor's Degree or higher preferred; ideally in a science-related discipline.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Understanding of Lean Six Sigma Methodology is preferred.
* You must have a Stamp 1 G or a Stamp 4 visa to apply.