Biopharma QC Analyst — GMP Lab & Method Transfer

R&D Partners; Shannon; On-site; EUR 42,000 - 60,000; Full time

Job summary

R&D Partners is seeking a QC Analyst to join a growing biopharmaceutical organisation supporting the manufacture and release of advanced biologic and gene therapy products within a GMP-regulated environment.

You will perform routine QC testing, support method transfers, equipment qualification and quality compliance activities, ensuring data integrity and GDP compliance across the QC laboratory.

Qualifications

• BSc or equivalent qualification in Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, Molecular Biology or a related scientific discipline.
• Minimum 2 years' experience working within a GMP-regulated pharmaceutical, biotechnology, biologics or advanced therapeutics environment.
• Hands-on qPCR experience is essential, alongside practical experience with techniques such as HPLC, Western Blot, SDS-PAGE, DNA extraction and spectrophotometry.
• Proven experience supporting the testing of large-molecule, biologics, gene therapy, cell therapy, vaccine or other advanced therapeutic products.
• Experience with analytical method transfer, equipment qualification, assay validation and routine QC testing activities.
• Experience with mammalian cell culture and/or flow cytometry would be advantageous but is not essential.

Responsibilities

• Perform routine QC testing to support in-process, stability and batch release activities using techniques including qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction and spectrophotometry.
• Support the testing of biologic and gene therapy products, ensuring analytical results are generated and reported accurately and in accordance with GMP requirements.
• Execute and support equipment qualification, assay validation, method transfer and method verification activities within the QC laboratory.
• Maintain laboratory equipment, ensuring calibration, routine maintenance and suitability for use in line with testing schedules.
• Investigate OOS results, deviations and non-conformances, supporting CAPAs, change controls and continuous improvement initiatives.
• Review and maintain GMP documentation including SOPs, laboratory records and quality system documentation whilst ensuring data integrity and GDP compliance.
• Strong understanding of GMP, GDP and Data Integrity requirements within a regulated pharmaceutical or biotechnology environment.
• Excellent analytical and problem-solving skills with the ability to investigate trends, anomalies and laboratory issues effectively.
• High attention to detail with a commitment to delivering accurate, high-quality analytical data.
• Strong organisational skills with the ability to manage multiple priorities in a fast-paced environment.
• Effective written and verbal communication skills, including technical documentation and cross-functional collaboration.
• Proactive mindset with a continuous improvement approach and willingness to learn new systems, technologies and laboratory techniques.

Skills

qPCR

HPLC

Western Blot

SDS-PAGE

DNA extraction

spectrophotometry

GMP compliance

GDP compliance

Data Integrity

Analytical thinking

Education

BSc or equivalent in Biochemistry/ Biotechnology/ Pharmaceutical Sciences/ Chemistry/ Molecular Biology

Tools

qPCR instruments

HPLC systems

Western blot equipment

Job description

R&D Partners is seeking a QC Analyst to join a growing biopharmaceutical organisation supporting the manufacture and release of advanced biologic and gene therapy products within a GMP-regulated environment.

You will perform routine QC testing, support method transfers, equipment qualification and quality compliance activities, ensuring data integrity and GDP compliance across the QC laboratory.