Quality Control Analyst

PE Global; Carlow; On-site; EUR 45,000 - 65,000; Full time

Job summary

PE Global is recruiting a QC Analyst for a pharmaceutical client in Carlow on an 11-month contract. The role follows a 2-cycle shift pattern: 7am-3pm week 1 and 3pm-11pm week 2, with duties across QC testing, documentation, and compliance.

The candidate will perform ELISA, HPLC, and compendial assays, participate in audits, and support continuous improvement initiatives within a cGMP/cGLP framework.

Qualifications

• Bachelor's degree or higher in Analytical Chemistry or Biochemistry or related field.
• 4+ years in a pharmaceutical laboratory.
• Experience with HPLC is desirable.
• Experience with ELISA and Softmax Pro software desirable.
• Knowledge of cGMP, GLP, and Quality Management Systems.

Responsibilities

• Work under the QC Manager following cGMP and cGLP policies and regulatory requirements.
• Participate in QC Tier 1 daily meetings and communicate testing progress and deviations.
• Write/revise/roll out standard operating procedures and training materials for QMS.
• Operate as part of the QC team performing testing and reviews.
• Perform analytical techniques including ELISA/HPLC/Compendial assays in GMP.
• Peer review testing documentation and ensure data integrity and QC KPIs.
• Support OOS investigations and audit/inspection readiness.
• Assist in internal/external audits as auditee for assigned areas.
• Drive continuous improvement, perform root cause analysis on equipment/system issues.

Skills

Quality control

Analytical thinking

Documentation

Education

Bachelor's degree or higher

Analytical Chemistry/Biochemistry background

Tools

HPLC

ELISA

Softmax Pro

Job description

The Role

PE Global are recruiting for a QC Analyst for our pharmaceutical client based in Carlow. This is an initial 11-month contract role.

The team works a 2-cycle shift pattern. 7am-3pm week 1. 3pm-11pm week 2

Job Responsibilities

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and review
• Perform various analytical techniques including but not limited ELISA/HPLC/Compendial Assays in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Participate in the laboratory aspects of OOS investigations
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues

Education & Experience

• Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
• 4+ years of experience in a pharmaceutical laboratory
• A good working knowledge of HPLC systems and software is desirable
• A good working knowledge of ELISA and Softmax Pro software is desirable
• A good knowledge of cGMP, GLP, Quality Management Systems

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****