Senior QA Specialist

Posted 3 Days Ago
Be an Early Applicant
Ordes, La Coruña, Galicia, ESP
In-Office
Senior level
Artificial Intelligence • Healthtech • Analytics • Biotech
The Role
Support QA for radiopharmacy operations in Galicia by maintaining and improving the QMS, ensuring EU GMP compliance, review/approve quality documentation, manage investigations, CAPA, change control and risk management, maintain inspection readiness, and collaborate with local and global teams to protect patient safety and product quality.
Summary Generated by Built In
Job Description SummaryWe are looking for a motivated and proactive Sr. Quality Assurance Specialist to join the Quality Assurance team supporting Radiopharmacy operations in Galicia, Spain.
The successful candidate will work closely with the Responsible Pharmacist, the Technicians team in Galicia, the QA team that is mainly based in the Netherlands and other local and global functions to ensure compliance with applicable Good Manufacturing Practices (GMP), radiopharmacy regulations, and company quality standards.
This role is critical in supporting the continuous improvement of the Quality Management System (QMS), maintaining inspection readiness, and ensuring that patient safety, product quality, and regulatory compliance remain central to daily operations.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.

Job Description

The Quality Assurance department is responsible for maintaining and continuously improving the QMS, reviewing and approving quality-related documentation, supporting operational activities, and driving compliance and quality improvement initiatives.

Required Qualifications
  • Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or another relevant scientific discipline.

  • Minimum of 3 years of experience in a GMP-regulated pharmaceutical, radiopharmaceutical, biotechnology, or medical device environment.

  • Experience working within Quality Assurance, Quality Systems, or a closely related function.

  • Strong knowledge of EU GMP requirements and pharmaceutical quality systems.

  • Experience with investigations, CAPA management, change control, and risk management processes.

  • Professional proficiency in Spanish and English, both written and spoken.

Preferred Qualifications
  • Experience in radiopharmaceutical manufacturing or hospital radiopharmacy operations.

  • Experience supporting regulatory inspections and inspection readiness activities.

  • Knowledge of validation and qualification activities.

  • Experience using electronic quality management systems (eQMS).

Competencies
  • Strong commitment to quality, patient safety, and regulatory compliance.

  • Excellent analytical and problem-solving skills.

  • Ability to challenge existing processes constructively and drive improvements.

  • Detail-oriented, with a high level of accuracy and integrity.

  • Strong organizational and project management skills.

  • Effective communicator with the ability to collaborate across multiple departments.

  • Proactive, self-motivated, and capable of working independently.

  • Pragmatic and results-oriented, with a focus on sustainable solutions.

  • Ability to manage multiple priorities in a fast-paced environment.

  • Continuous improvement mindset with a passion for operational excellence.

What We Offer
  • Opportunity to contribute to a radiopharmacy organization that directly supports patient care

  • A collaborative and quality-focused work environment.

  • Professional development and training opportunities.

  • The chance to make a meaningful impact on quality, compliance, and operational excellence within a highly regulated healthcare setting.

Inclusion and 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 expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviours:

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.

#LI-Hybrid

#LI-AV1

Additional Information

Relocation Assistance Provided: No

Skills Required

  • Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or another relevant scientific discipline.
  • Minimum of 3 years of experience in a GMP-regulated pharmaceutical, radiopharmaceutical, biotechnology, or medical device environment.
  • Experience working within Quality Assurance, Quality Systems, or a closely related function.
  • Strong knowledge of EU GMP requirements and pharmaceutical quality systems.
  • Experience with investigations, CAPA management, change control, and risk management processes.
  • Professional proficiency in Spanish and English, both written and spoken.
  • Experience in radiopharmaceutical manufacturing or hospital radiopharmacy operations.
  • Experience supporting regulatory inspections and inspection readiness activities.
  • Knowledge of validation and qualification activities.
  • Experience using electronic quality management systems (eQMS).

GE Healthcare Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.

  • Healthcare Strength Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
  • Retirement Support Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
  • Strong & Reliable Incentives Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.

GE Healthcare Insights

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The Company
HQ: Chicago, IL
50,282 Employees
Year Founded: 1892

What We Do

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.

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