Senior Associate, Quality Assurance (24/7 Shift)

Overview

This role is for a Senior Associate in Quality Assurance who will report to the QA Manager and act as a key member of the site QA function. The position serves as the main QA contact for Manufacturing Quality Assurance activities and supports a culture of ongoing improvement across site processes and practices. Along with standard QA duties, the role may also involve additional assignments that contribute to continuous improvement efforts. This is a 24/7 shift position supporting manufacturing operations.

The manufacturing QA function operates as one integrated team with oversight responsibilities across aseptic manufacturing activities, including formulation and filling, as well as inspection and packaging operations.

Key Responsibilities

• Carry out all work in line with company safety requirements and approved SOPs.
• Provide live quality oversight and support directly on the manufacturing floor, covering formulation, aseptic filling, inspection, or packaging based on the operating unit.
• Conduct manual visual inspection of vials and syringes.
• Take part in investigations related to customer complaints.
• Complete in-process checks whenever required.
• Support the assessment and investigation of all deviation categories, including triage activities.
• Review and approve deviations for closure, ensuring the supporting documentation is complete and compliant.
• Examine and sign off batch records and related documents ahead of Qualified Person release activities.
• Train and guide site personnel so they can carry out their assigned duties effectively.
• Draft, review, and approve standard operating procedures in alignment with company policies.
• Contribute to continuous improvement and operational excellence programs.
• Handle additional tasks or project work as assigned by the manager.

Qualifications and Experience

A university degree is required, ideally in Engineering or a Science-related field. Candidates should bring at least 4 years of relevant experience in the pharmaceutical or biotechnology sector, or an equivalent mix of education and experience that meets the role expectations.

Preferred Attributes

• Strong written and spoken communication skills.
• Ability to work effectively with cross-functional teams and make sound decisions.
• Well-developed organizational skills with the discipline to complete assigned work.
• Good problem-solving ability, including hands-on experience with root cause analysis and deviation investigations.
• Experience with combination products or devices in packaging-related or complaint-handling work is advantageous for Inspection & Packaging roles, though it is not required for Formulation & Aseptic Filling roles.
• Familiarity with relevant regulatory expectations and the ability to assess compliance concerns.
• Background in Operational Excellence initiatives.

Work Arrangement

This is a site-based role in Dublin, County Dublin, Ireland and requires participation in a 24/7 shift schedule to support manufacturing needs.