GMP QA Shift Specialist – On-Site (Cork)

Biopharma Careers

Cork

Hybrid

EUR 70,000 - 100,000

Full time

9 days ago

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Job summary

Johnson & Johnson is seeking a Quality Assurance Specialist to provide on-floor QA presence in Ringaskiddy, Cork, ensuring GMP compliance and robust quality systems. The role covers nonconformance handling, change control, document control, supplier qualification and audit readiness in a 4-cycle shift environment.

The ideal candidate holds a science degree with 3–5 years in QA/manufacturing, strong GMP knowledge, and demonstrated leadership on the manufacturing floor. On-site work only.

Qualifications

  • Bachelor's degree in science or technical field required.
  • 3–5 years in quality, manufacturing, validation or compliance.
  • Knowledge of FDA/EMEA GMP requirements applies.
  • Experience with GMP and quality systems is expected.
  • Shift work experience is desirable.
  • Strong leadership and quality decision-making on the floor.

Responsibilities

  • Provide routine QA presence on the manufacturing floor.
  • Ensure GMP compliance with site procedures and regs.
  • Perform GMP walkdowns and quality audits as needed.
  • Manage nonconformances, CAPA and change control processes.
  • Oversee document control and supplier qualification activities.
  • Support training, inspection readiness and audit activity.
  • Coordinate site change control board meetings and approvals.

Skills

QA Operations
GMP Compliance
Quality Assurance
On-floor Presence
Leadership
Audit Readiness
Documentation

Education

Bachelors Degree in Science

Tools

SAP
LIMS

Job description

Johnson & Johnson is seeking a Quality Assurance Specialist to provide on-floor QA presence in Ringaskiddy, Cork, ensuring GMP compliance and robust quality systems. The role covers nonconformance handling, change control, document control, supplier qualification and audit readiness in a 4-cycle shift environment.

The ideal candidate holds a science degree with 3–5 years in QA/manufacturing, strong GMP knowledge, and demonstrated leadership on the manufacturing floor. On-site work only.

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