QC Analyst

Aphex Group; Carlow; On-site; EUR 40,000 - 60,000; Full time

Job summary

Aphex Group seeks a QC Analyst to join the Quality Operations Laboratory in Ireland. The role supports analytical method transfer, validation, and routine commercial testing to ensure regulatory compliance.

You will perform HPLC, immunoassays, and cell-based assays, contribute to data integrity, and participate in audit readiness and continuous improvement within QC.

Qualifications

• Bachelor’s degree or higher in Analytical Chemistry, Biochemistry, or related field.
• 2–3 years pharmaceutical lab experience preferred, especially HPLC and cell-based assays.
• Good knowledge of cGMP/GLP and Quality Management Systems.

Responsibilities

• Work under QC Manager to ensure compliance with cGMP and cGLP.
• Perform analytical testing and data review to support product release.
• Help write/roll out SOPs and training materials for QC processes.
• Conduct various analytical techniques including HPLC, immunoassays, and cell-based assays.
• Assist in internal and external audits and inspection readiness.

Skills

Analytical chemistry

HPLC

Cell culture

Immunoassay

Data integrity

Education

Bachelor’s degree or higher in Analytical Chemistry or Biochemistry

Tools

HPLC instruments

Laboratory software

Job description

QC Analyst - Quality Operations Laboratory

Purpose The QC group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with incredibly high standards of quality and meets all regulatory requirements. Partnering across internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The QC Analyst (Quality Operations) will report directly to the QC Manager and will help in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing.

This role follows a 2 cycle shift pattern. Occasional travel may be required for training purposes.

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 laboratory-based duties
• Perform various analytical techniques including but not limited to HPLC, (HIC,CE, IEX, HP-SEC), ELISA, Cell Based Assay, Cell Culture, Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Ensure timely completion of all assigned data processing and reviewing.
• 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 e.g., FMEA, Fishbone diagrams, 5 why's etc,
• Work collaboratively to drive a safe and compliant culture on site.

Qualifications

• Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
• The ideal candidate will have 2- 3 years' experience in a pharmaceutical laboratory, ideally with experience in HPLC / Cell based assays and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products.
• A good working knowledge of Immunoassay, Cell Culture, HPLC systems and software is desirable
• A good knowledge of cGMP, GLP, Quality Management Systems