QC Lead Analyst — Biologics & Vaccines (2-Shift)

Morgan McKinley; Carlow; On-site; EUR 70,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a QC Lead Analyst for a state-of-the-art Quality Control laboratory in Ireland. You will lead analytical testing transfers, validation and release testing for vaccines and biologics, working under the QC Manager in a two-cycle rotating shift pattern.

You will apply ELISA, HPLC and compendial methods, drive CAPA and audits, and contribute to continuous improvement within a compliant GMP environment. A minimum 4 years in pharma labs is required.

Qualifications

• Bachelor's degree or higher in Analytical Chemistry, Biochemistry or a closely related science.
• At least 4 years’ experience in a pharmaceutical laboratory.
• Good working knowledge of HPLC systems and associated software.
• Good working knowledge of ELISA techniques and SoftMax Pro software.
• Sound understanding of cGMP, GLP and Quality Management Systems.

Responsibilities

• Work under the direction of the QC Manager, ensuring compliance with safety policies, cGMP, cGLP and regulatory requirements.
• Participate in daily QC meetings, communicating testing progress and deviations.
• Contribute to writing and revision of SOPs, training materials and quality documentation.
• Carry out allocated analytical testing and review activities as part of the QC team.
• Perform ELISA, HPLC and compendial assays in accordance with GMP requirements.
• Peer-review testing documentation to ensure data integrity and QFTime KPIs.
• Help with laboratory investigations related to OOS results.
• Support audits and inspections to maintain compliance and readiness.
• Participate in internal/external audits as an auditee for assigned areas.
• Drive continuous improvement using root cause analysis and tools like FMEA and 5 Whys.
• Collaborate to promote a safe, compliant, quality-focused lab culture.

Skills

ELISA

HPLC

Compendial testing

cGMP knowledge

Education

Bachelor's degree or higher in Analytical Chemistry / Biochemistry or related

Tools

SoftMax Pro

Job description

Morgan McKinley is seeking a QC Lead Analyst for a state-of-the-art Quality Control laboratory in Ireland. You will lead analytical testing transfers, validation and release testing for vaccines and biologics, working under the QC Manager in a two-cycle rotating shift pattern.

You will apply ELISA, HPLC and compendial methods, drive CAPA and audits, and contribute to continuous improvement within a compliant GMP environment. A minimum 4 years in pharma labs is required.