Biopharma QC Analyst — GMP High-Throughput Lab

Johnson Johnson; Cork; Presencial; EUR 30 000 - 47 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

12-month contract

On-site work

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

HPLC

cIEF

cSDS

ALCOA+ data integrity

GDP knowledge

Deviation/non-conformance mgmt.

Formação académica

Third level qualification in scientific/technical discipline

Ferramentas

Empower software

Descrição da oferta de emprego

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