QC Specialist Separations

About Johnson & Johnson MedTech

Johnson & Johnson leads in healthcare innovation, aiming to prevent, treat, and cure complex diseases with smarter, less invasive personalized solutions. Our expertise spans Innovative Medicine and MedTech, enabling us to pioneer healthcare advancements and profoundly impact global health.

Role Overview

We are seeking a QC Specialist in Separations to join our Quality Control team in Ringaskiddy, County Cork, Ireland. This position supports Quality Control laboratory activities within a regulated pharmaceutical manufacturing setting, collaborating with laboratory and cross-functional teams to aid analytical testing, equipment qualification, method transfer, investigations, and continuous improvement projects.

Key Responsibilities

• Assist with daily testing operations and ensure compliant Quality Control processes.
• Coordinate qualification of analytical instruments such as HPLC, Spectrophotometry, Nephelometry, and Total Organic Carbon analyzers.
• Oversee sampling and analysis during plant and laboratory utility qualification.
• Manage analytical method transfers related to New Molecular Entities (NMEs).
• Facilitate testing and sampling of raw materials, utilities, in-process samples, bulk and finished products.
• Support analyst training programs and train laboratory staff on analytical technologies.
• Review and approve laboratory data, QC investigations, deviations, CAPAs, and Change Controls.
• Plan and conduct laboratory projects including method transfers and equipment qualifications.
• Identify opportunities for process improvements and support lean initiatives.
• Present analytical and technical data clearly to stakeholders and regulatory authorities.
• Maintain up-to-date knowledge of analytical technologies and regulatory compliance trends.

Qualifications and Requirements

• At least 3 years of pharmaceutical industry experience.
• Previous supervisory experience in an IMB/FDA-regulated environment.
• Knowledge of FDA and EMA regulations relevant to biologics and pharmaceuticals.
• Strong technical expertise in analytical techniques and lab equipment used in Chemistry, Biochemistry, or Microbiology.
• Experience supporting analytical testing, equipment qualification, and method transfer protocols.

Skills and Competencies

• Collaborative teamwork and the ability to build productive relationships.
• Critical thinking, problem-solving skills, and high attention to detail.
• Result-driven mindset with integrity, accountability, and customer focus.
• Coaching and mentoring capabilities.
• Effective communication, adaptability, and innovative thinking.
• Inclusive working approach and openness to diverse perspectives.
• Understanding of AI concepts and ethical practices to enhance efficiency.

Additional Information

Employees must adhere to Environmental, Health & Safety policies and comply with applicable regulations. Interaction with regulatory inspectors and participation in audits is expected. Johnson & Johnson is an equal opportunity employer, encouraging diverse applicants. Reasonable accommodations are available upon request during recruitment and onboarding processes.

Compensation and Benefits

The anticipated annual salary range is €52,400 to €82,915. Benefits include an annual bonus based on individual and company performance, vacation, parental leave, bereavement and caregiver leave, volunteer opportunities, well-being reimbursements, various insurance plans, and recognition awards. Actual benefits may differ by location and are subject to change.