Quality Control Analyst – Bioassay

Johnson & Johnson Johnson & Johnson · Pharma · Ringaskiddy, Cork, Ireland

Quality Control Analyst responsible for bioassay testing, laboratory utilities, and equipment in compliance with Good Manufacturing Practice (GMP) in a pharmaceutical setting. This role involves performing routine and non-routine analytical testing, method validation, technical transfer, equipment operation, maintenance, calibration, troubleshooting, and managing deviations. The analyst will also be involved in writing and reviewing laboratory documentation and supporting team activities.

What you'd actually do

  1. Performing routine and non‑routine analytical and bioassay testing, including method validation and technical transfer activities in line with ICH, CFR, USP, and EP guidelines
  2. Executing validation, operation, maintenance, calibration, and troubleshooting of laboratory equipment and associated software
  3. Writing, executing, reporting, reviewing, and approving IQ/OQ/PQ protocols to ensure equipment is qualified for cGMP use
  4. Reviewing and approving laboratory test results (where appropriate) and ensuring testing and approvals are completed within agreed turnaround times
  5. Writing and reviewing laboratory Technical Manuals (TMs), SOPs, and Work Instructions (WIs) in accordance with company policies

Skills

Required

  • Third‑level qualification in a scientific or technical discipline
  • Minimum of 2 years’ experience in a laboratory testing environment within the biological and/or pharmaceutical industry
  • Demonstrated knowledge and testing experience in an FDA / IMB‑approved QC laboratory
  • Knowledge of FDA and EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
  • Strong written and verbal communication skills
  • Strong attention to detail, problem‑solving ability, and analytical thinking
  • Ability to work effectively in a collaborative, cross‑functional environment
  • Results‑ and performance‑driven, adaptable, and flexible approach

What the JD emphasized

  • FDA / IMB‑approved QC laboratory
  • FDA and EMEA regulatory requirements applicable to biologics and/or pharmaceuticals