Quality Control Analyst

Johnson Johnson; Cork; On-site; EUR 30,000 - 47,000; Full time

Benefits offered by this job

12-month contract

On-site work

Job summary

Johnson & Johnson Innovative Medicine is seeking an on-site QC analyst in Cork to perform routine and non-routine analytical testing, method validation, and transfers within the Separations lab. You will handle equipment calibration, IQ/OQ/PQ activities, and ensure timely review of results in a fast-paced GMP setting.

The role requires a third level qualification in a scientific discipline, 2+ years in pharma/biotech labs, and hands-on HPLC, cIEF, cSDS experience, with Empower software and

Qualifications

• A third level qualification in a scientific/technical discipline.
• Minimum of 2 years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
• Ability to work in a fast-paced, high-throughput environment.
• Strong understanding of data integrity principles (ALCOA+) and GDP.
• Approximately 1 year of experience in a pharmaceutical or biopharmaceutical GMP laboratory.
• Hands-on experience with separations-based analytical techniques (e.g., HPLC, cIEF, cSDS).
• Experience with Empower software.
• Familiarity with deviation/non-conformance management.
• Graduate candidates who can demonstrate relevant knowledge, practical exposure, or transferable experience may also be considered.

Responsibilities

• Achieves competency in JSI laboratory methods and procedures, and trains other QC analysts when required.
• Performs routine/non-routine analytical testing, method validation, and technical transfer activities to ensure compliance with ICH, CFR, USP, and EP guidelines.
• Executes validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software, including writing, executing, reporting, and reviewing IQ/OQ and PQ protocols for cGMP qualification.
• Reviews and approves laboratory test results where appropriate, ensuring testing and approvals are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs, and WIs in alignment with company policy and product licence commitments.
• Ensures QC activities comply with cGMP, EHS policies, Safety Statement, site manual, local legislation, and company quality standards.
• Actively participates in the QC group, assists with group activities, communicates issues to the QC Team Leader/Manager, anticipates future requirements, and deputizes for the QC Team Leader as appropriate.
• Deals with non-conformances and deviations in an accurate and timely manner.
• Maintains and develops knowledge of analytical technology and cGMP standards while facilitating continuous improvement.
• Collaborates as a strategic partner with other site departments, demonstrating excellent interpersonal, teamwork, customer focus, and communication skills.
• Demonstrates core competencies including problem-solving, innovation, adaptability, attention to detail, strategic thinking, and adherence to the Credo value of integrity.
• Builds strong, productive relationships, influences others constructively, seeks professional development, and uses best practices to improve business operations.
• Holds self accountable for compliant, flawless execution, personal decisions, and adapting to change.
• Demonstrates courage to express differing opinions, listens effectively, works with diverse teams, and maintains high ethical standards, treating people with dignity and respect.
• Takes reasonable care for personal and colleague safety, uses PPE, reports incidents/unsafe conditions, participates in EHS teams, and suggests workplace health and safety improvements.

Skills

HPLC

cIEF

cSDS

ALCOA+ data integrity

GDP knowledge

Deviation/non-conformance mgmt.

Education

Third level qualification in scientific/technical discipline

Tools

Empower software

Job description

Working mode: On-site (laboratory based hands-on role)

Working hours: 39 hours per week (Days, usual business hours)

Imagine your next project advancing healthcare and ensuring the identity, purity, and quality of biopharmaceutical products within a fast-paced, high-throughput GMP environment.

This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at Janssen Sciences Ireland (JSI) as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

The team operates within the Quality Control (QC) function, specifically the Separations laboratory. It is a group of 33 individuals structured around three core technology-based pillars to provide technical expertise and efficient delivery. The team is led by a manager and supported by team leads, specialists, and technical experts. Key activities include routine testing, project support (such as Process Performance Qualification and method transfers), and quality system ownership within a fast-paced GMP-regulated environment. The hiring process consists of a single-stage competency-based interview. The team is looking to hire as soon as possible.

roles and responsibilities

• Achieves competency in JSI laboratory methods and procedures, and trains other QC analysts when required.
• Performs routine/non-routine analytical testing, method validation, and technical transfer activities to ensure compliance with ICH, CFR, USP, and EP guidelines.
• Executes validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software, including writing, executing, reporting, and reviewing IQ/OQ and PQ protocols for cGMP qualification.
• Reviews and approves laboratory test results where appropriate, ensuring testing and approvals are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs, and WIs in alignment with company policy and product licence commitments.
• Ensures QC activities comply with cGMP, EHS policies, Safety Statement, site manual, local legislation, and company quality standards.
• Actively participates in the QC group, assists with group activities, communicates issues to the QC Team Leader/Manager, anticipates future requirements, and deputizes for the QC Team Leader as appropriate.
• Deals with non-conformances and deviations in an accurate and timely manner.
• Maintains and develops knowledge of analytical technology and cGMP standards while facilitating continuous improvement.
• Collaborates as a strategic partner with other site departments, demonstrating excellent interpersonal, teamwork, customer focus, and communication skills.
• Demonstrates core competencies including problem-solving, innovation, adaptability, attention to detail, strategic thinking, and adherence to the Credo value of integrity.
• Builds strong, productive relationships, influences others constructively, seeks professional development, and uses best practices to improve business operations.
• Holds self accountable for compliant, flawless execution, personal decisions, and adapting to change.
• Demonstrates courage to express differing opinions, listens effectively, works with diverse teams, and maintains high ethical standards, treating people with dignity and respect.
• Takes reasonable care for personal and colleague safety, uses PPE, reports incidents/unsafe conditions, participates in EHS teams, and suggests workplace health and safety improvements.

how to succeed

• A third level qualification in a scientific/technical discipline required.
• A minimum of 2 years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
• Ability to work in a fast-paced, high-throughput environment.
• Strong understanding of data integrity principles (ALCOA+) and Good Documentation Practices (GDP).
• Approximately 1 year of experience in a pharmaceutical or biopharmaceutical GMP laboratory.
• Hands‑on experience with separations‑based analytical techniques (e.g., HPLC, cIEF, cSDS).
• Experience with Empower software.
• Familiarity with deviation/non‑conformance management.
• Graduate candidates who can demonstrate relevant knowledge, practical exposure, or transferable experience may also be considered.

This role offers a very competitive hourly rate. This contract will run initially for 12 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science‑based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.