QA Associate

Job Description Summary

As the QA Associate, reporting to the QA Lead, you will be responsible for ensuring all batch release activities are performed in a timely, compliant, and efficient manner to meet both quality and logistical requirements. You will bring a strong quality perspective to the role, delivering customer and business needs as measured by the balanced scorecard, while operating safely and in full compliance with GMP, Quality, and EHS standards. Working closely with cross‑functional teams, you will help drive quality excellence and execution across the value stream, support Quality Operations across the campus, and contribute to a high‑performance culture focused on continuous improvement through a LEAN mindset, strong collaboration, and consistent delivery on commitments.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE HealthCare Ireland Limited manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of GE HealthCare, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time here at our campus at Carrigtohill, Co. Cork.

Every second of every day, 365 days a year, a patient is diagnosed with the help of our products through procedures such as X-Ray and MRI. We are a modern, agile, cost competitive team delivering to the highest standards of safety, quality, and compliance to patients around the world.

Job Description

Responsibilities

• Quality Assurance: Keep colleagues informed of current issues and developments as appropriate. Ensuring compliance with all regulatory/company guidelines. Adhering to Operational Excellence within the QA Department

• Process Improvement: Support quality improvement initiatives to continuously improve QA processes, methodologies, and tools to enhance efficiency and effectiveness.

• Daily Management System: Maintain the retention program from a Quality perspective. Maintain departmental metrics ensuring on time batch release is consistently achieved. Generation/ reporting of Key performance indicators for the group as required.

• Batch Release: Support the quality review of batch related documentation prior to certification by QP in accordance with GMP regulations. Review and approve deviations & investigations related to product quality to support timely closeout of quality records.

• Collaboration: Collaborate with cross-functional teams to ensure seamless communication and understanding of quality objectives and ensure appropriate action is taken to support on site investigations. Liaising with internal and external customers e.g., planning/ QA/ Production etc.

• Training and Development: Provide training as required to team members to enhance their technical skills and knowledge of QA practices. Perform cross training in order to ensure flexibility within the QA department. Ensure all training is current and completed on time.

• Risk Management: Identify and assist in mitigating risks ensuring timely resolution of issues.

• Documentation: Management of site archive, storage, retrieval and destruction processes

• Audit Readiness: Assure site and business is properly prepared for external and internal compliance inspections. Support and participate in site internal audits, Regulatory audits and third party audits. Collaborate closely with business partners to ensure site is audit ready at all times

• Ensuring compliance to company administrative procedures and policies in the department

• Ensuring compliance with EHS at all times, and actively participate in EHS activities.

• Approving validation documentation and ensuring Validation activities are carried out in compliance with, cGMP and company Quality standards

• Completing a reasonable level of overtime as required to facilitate the business needs.

• Carrying out additional duties as deemed necessary by the Quality leader.

Qualifications and Requirements

• You have achieved at least a Professional Level 8 degree qualification

• Basic experience working within a GMP environment

• Ability to work on own initiative & judgement with minimal supervision

• Clear thinker who can analyze data to establish a direction to proceed

• Relevant working Knowledge of a regulated Industry

• Highly organised and attentive to detail

• Capability of handling multiple tasks effectively and meeting critical deadlines

• Strong verbal and written skills

• A high degree of computer literacy

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

 

Inclusion & Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.

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Additional Information