Quality Control Analyst Ip

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

Quality Control Analyst role at Johnson & Johnson focused on bioassay testing, laboratory utilities, and equipment in a GMP environment. Responsibilities include performing analytical testing, method validation, equipment operation and calibration, writing and reviewing protocols and documentation, and managing deviations. Requires a scientific/technical degree and experience in a pharmaceutical QC lab with knowledge of regulatory requirements.

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

  • A third‑level qualification in a scientific or technical discipline
  • A 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 analytical, problem‑solving, and decision‑making skills
  • Excellent written and verbal communication skills
  • High attention to detail with a results‑ and performance‑driven mindset
  • Ability to work effectively as part of a collaborative, cross‑functional team

Nice to have

  • Analytical Reasoning
  • Business Behavior
  • Compliance Management
  • Continuous Improvement
  • Controls Compliance
  • Data Analysis
  • Execution Focus
  • ISO 9001
  • Persistence and Tenacity
  • Quality Control (QC)
  • Quality Control Testing
  • Quality Standards
  • Quality Systems Documentation
  • Report Writing
  • Sample Testing
  • Technologically Savvy

What the JD emphasized

  • GMP
  • FDA / IMB‑approved QC laboratory
  • FDA and EMEA regulatory requirements