Senior QA Packaging Associate

Senior QA Packaging Associate

Shanbally, Ringaskiddy, Cork

QA Operations – Packaging

Onsite, shift-based role (2 Shift)

Closing Date: 23rd October 2026

Summary Description

BioMarin is a high-performing, team-based organisation where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy, motivation and organisational capability are key requirements for this role.

The Senior QA Packaging Associate is a shift-based role within QA Operations Packaging, responsible for providing Quality oversight, support and technical guidance for Packaging and Finished Goods activities in line with current Good Manufacturing Practice requirements, regulatory expectations and BioMarin procedures.

In addition to performing the core day-to-day responsibilities of a QA Associate, the Senior QA Packaging Associate will act as the main Quality point of contact on shift for escalations, coaching and real-time decision support. The role is intended to strengthen ownership, accountability and capability across the shift team, while supporting robust Quality decision-making, process team representation, continuous improvement and effective RCAR participation.

Responsibilities

• Provide Quality oversight, support and guidance for Packaging and Finished Goods activities in accordance with GMP, regulatory expectations, customer requirements and BioMarin procedures.

• Compile and review Lot Release Packs, executed packaging batch records and associated documentation to ensure accuracy, completeness and compliance prior to release.

• Support Secondary Packaging Operations, including Quality presence on the floor, review of routine activities and performance of Acceptable Quality Level inspections, as required.

• Act as the main Quality point of contact on shift for escalations, Quality queries and real-time decision support, while ensuring other members of the team remain accountable for decision making

• Coach, support and guide QA Associates and operational colleagues on shift to assess issues, make sound GMP decisions, progress actions and strengthen right-first-time behaviours.

• Represent Quality on relevant process teams, shift forums and cross-functional meetings, ensuring Quality risks, escalations, actions and improvement opportunities are clearly communicated and progressed.

• Drive and support continuous improvement initiatives that improve compliance, documentation quality, process robustness, cycle time, right-first-time performance and team capability.

• Lead and participate in RCARs, deviations, investigations, customer complaints and related Quality activities to ensure robust root cause analysis and effective corrective and preventative actions.

• Write, review and approve Standard Operating Procedures, Work Instructions and other GMP documentation in accordance with BioMarin policies and site procedures.

• Support Quality metrics, trend reviews, batch listing activities, Product Quality Review inputs and other Quality systems activities, as required.

• Scope

• Shift-based position supporting Packaging and Finished Goods operations.

• Provides Quality oversight and escalation support during routine and non-routine Packaging activities.

• Acts as a key Quality contact for the shift team, while ensuring ownership and accountability is maintained among all members of the team.

• Works cross-functionally with Packaging Operations, Supply and Distribution, Maintenance, Quality Control and other site functions.

• Supports delivery of site, departmental and shift objectives through Quality oversight, coaching, investigation support and continuous improvement.

• Education and Experience

• Degree qualification in a scientific, quality, engineering or related discipline is desirable.

• Relevant experience in a GMP-regulated pharmaceutical, biotechnology or medical device environment.

• Experience in Quality Assurance, Packaging Operations, Finished Goods, Manufacturing Operations or a related GMP support function.

• Demonstrated understanding of GMP requirements, batch documentation, deviation management, investigations, CAPA and Quality systems.

• Experience supporting or leading investigations, RCARs, process improvements or cross-functional Quality activities is desirable.

• Skills and Competencies

• Strong Quality mindset with the ability to make timely, risk-based decisions in a GMP environment.

• Excellent communication and stakeholder management skills, with the ability to influence and coach others on shift.

• Ability to provide clear guidance during escalations while promoting ownership, accountability and effective follow-through.

• Strong technical writing, documentation review and attention to detail.

• Effective problem-solving skills with experience using root cause analysis tools and continuous improvement approaches.

• Ability to work independently and collaboratively in a fast-paced shift environment.

• Flexible, proactive and organised, with the ability to prioritise work and support competing business needs.

• Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

• Equal Opportunity Employer/Veterans/Disabled

• An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

• Ireland Safety Responsibility

• Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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