Function
Quality
Sub function
Quality Control
Category
Expert Technician, Quality Control (S5)
Location
Ringaskiddy / Ireland
Date posted
Jul 01 2025
Requisition number
R-019330
Work pattern
Fully Onsite
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

JOB DESCRIPTION:

Position Title: QC Technical Expert
Department Name: Quality Control
Reports To: QC Team Lead

POSITION SUMMARY:

We are seeking a highly skilled QC Technical Expert with a strong technical background in analytical techniques, particularly in Microbiology, and a solid understanding of laboratory equipment. This individual will play a vital role in ensuring the quality and compliance of our biopharmaceutical processes.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s Degree in Chemistry, Biochemistry, Microbiology, or a related field.
• 4-6 years of relevant experience in the biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience.
• Knowledge of regulatory requirements, policies, and guidelines, with experience in QC document reviews and regulatory inspection processes.
• Familiarity with quality systems and strong technical expertise in QC analytical testing methods and equipment.
• Understanding of current Good Manufacturing Practices (cGMP) and FDA/EU guidelines is essential.

KEY RESPONSIBILITIES:

• Qualify analytical equipment and oversee related testing functions.
• Coordinate sampling and testing during plant and utility qualifications.
• Plan and manage the successful transfer of Analytical Methods for new market entries (NMEs).
• Oversee the analytical testing and sampling of raw materials, utilities, in-process, final bulk, and final products.
• Support and implement training programs for analysts.
• Contribute to end-to-end product launches and new product introduction (NPI) commitments to maintain high standards in operations.
• Serve as the lead for method verification related to product owner requests, ensuring on-time launches for NPIs.
  Collaborate with various departments and team leaders to ensure efficient completion of QC activities.

GENERAL SCOPE OF RESPONSIBILITIES:

• Assist the team leader with daily testing operations.
• Review and approve data and QC investigations.
• Assess and approve deviations, CAPAs, and Change Control.
• Plan and oversee laboratory projects, such as method transfers and equipment qualifications.
• Identify opportunities for lab process improvements and implement them proactively.
• Train laboratory staff on specific analytical technologies.
• Provide subject matter expert support on analytical technologies.
• Participate in lean initiatives focused on lab operations, advancing documentation and qualification processes.
• Present analytical data clearly to customers, regulatory inspectors, and internal teams.
• Stay current with emerging trends in analytical technology and compliance.

ESSENTIAL DUTIES:

• Support cGMP routine testing related to deviations, laboratory investigations, CAPAs, and out-of-specification (OOS) results.
• Conduct data review assignments per established laboratory procedures focused on data integrity and documentation.
• Author, review, and drive laboratory documents, including protocols, reports, and standard operating procedures.
• Operate and support laboratory instruments and equipment as necessary.
• Lead and train colleagues, providing expertise as needed.
• Initiate change requests in compliance with relevant procedures and policies.
• Promptly address non-conformances and initiate Quality Issues according to established procedures, participating in investigations and providing essential information for effective CAPA implementation.
• Offer strong technical and scientific support to both internal and external customers.
• Assist with the qualification or validation of methods for the Quality Control unit.
• Participate in and lead special projects as part of the QC analytical technical team.
• Ensure effective capacity planning and manage performance of assigned tasks.