16156377 – Quality Assurance Specialist – Dublin Contractor

This role is on a 6 Month contract with a view to extension.

Purpose

This position operates within the Supplier Quality team to support the qualification and post-qualification monitoring of Suppliers. The Supplier Quality team operates globally and sits within the wider Central Quality Systems and Compliance group. The incumbent will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the biopharma industry.

Responsibilities

• Support the Global Supplier approval and update processes.
• Support the Supplier Change Notification (SCN) process to ensure Supplier changes are reviewed and assigned to the appropriate owners.
• Support the Quality Agreement Management process.
• Support process performance projects as directed.
• Perform all responsibilities in accordance with company policies, procedures, federal regulations, and safety requirements.

Requirements

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology, or other science.
• Minimum of 2 years of experience in Quality with medical device, pharmaceutical, or biologics experience.
• This position requires the individual to understand and follow written SOPs, and record all work legibly and in real-time; close attention to detail is necessary.
• The person in this position will receive supervisory direction on all routine and non-routine activities. Routine activities will be unsupervised as training and competency development. The person in this position must have good organizational skills.

• The position requires the individual to work collaboratively with colleagues, peers, and managers.
• A good understanding of the concepts and systems applied to cGMP operations.
• The person will have experience with Technical Writing and Problem-Solving methods.
• Ability to perform assigned tasks and complete work on schedule
• Eagerness to learn and accept challenges
• Able to handle multiple tasks
• Strong communication skills
• Working knowledge of computer programs (Microsoft Word, Excel, PowerPoint)