QC Analyst

Role Summary:

• An exciting new opportunity has arisen for a Quality Control (QC) Analyst to join our client’s busy biopharmaceutical facility in Co. Waterford.
• The QC Analyst is responsible for sample receipt, testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations.
• Additional functions include raw material testing, stability testing, assay transfers, and qualification of
• The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group.
• Quality Control is also responsible for assisting in site wide studies and projects.

Core Duties and Responsibilities:

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOx) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.

Minimum Qualifications and Experience:

• Minimum of Degree Analytical Science or similar discipline.
• Minimum 1 year experience within a Pharmaceutical or Good Manufacturing Practices (GMP) environment.

Please note, we do not require agency assistance with this role.