33640-Quality Control NPI Senior Associate-Dublin Contractor

This is a 12-month contract with a view to extension. This is an onsite role.

Purpose

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample, and data management. Contributes to the  team by ensuring the quality of the tasks/services provided by self 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.
• 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.

Requirements

• 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
• Take initiative to identify and drive improvements
• Communication skills (verbal and written) at all levels
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Demonstrated ability to work independently and deliver right first-time results
• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies