Quality Control NPI – Senior Associate- Dublin Contractor

Purpose

Under minimal supervision, responsible for contributing to the team by ensuring the quality of the tasks/services provided by self and contributes to the completion of milestones associated with specific projects or activities within team.

This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Responsibilities

• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to QC projects and/or QC tasks within Site projects
• Plan and perform non-core testing related to NPI activities
• Manage all sample management activities related to NPI activities throughout the site
• Create/own and approve protocols, sample plans, SOP and documentation related to NPI
• QC Representative responsible for Method Validation and Transfers co-ordination and readiness
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities for NPI activities
• LIMS data coordination of non-core (NPI) activities.
• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Create APPX data files and randomisation memo to facilitate data analysis.
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

Qualifications

• Bachelor’s degree in a science discipline.
• 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Strong background in Chemistry and Analytical testing is required.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information
• Anticipates and prevents potential problems