Non-conformance Specialist (QC Microbiology)

We are searching for the best talent for Non-conformance Specialist (QC Microbiology) to be based in Leiden.

Join our QC Microbiology team to lead investigations that protect product quality and patient safety. You’ll manage non-conformance records, drive corrective actions, and help keep our labs inspection-ready while working closely with QC, QA, and manufacturing teams. English is required and Dutch is a plus!

As a non-conformance Specialist (QC Microbiology), you will:

• Lead thorough investigations of non-conformances in microbiology testing and related processes to protect product quality and safety.
• Define, coordinate, and implement corrections, CAPAs, ACTs, and effectiveness checks to close issues and prevent recurrence.
• Use structured root-cause methods (e.g., Fishbone, 5 Whys, KT) and interviews to identify causes and recommend robust corrective actions.
• Assess product impact and advise on disposition and regulatory/compliance implications.
• Maintain clear, timely documentation; contribute to trending and reporting for audits, inspections, and management review.
• Partner with QC, QA, manufacturing, and other teams to resolve quality issues, update procedures, and support continuous improvement.

Qualifications/Requirements:

• Bachelor’s or Master’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field; microbiology background is a strong advantage.
• 3 years’ (MSc) to 5 years’ (BSc) experience in QC, QA, or related roles in the pharmaceutical industry, with non-conformance/investigation exposure.
• Solid understanding of GMP and relevant guidelines (FDA, EMA, ICH) and quality procedures.
• Practical experience with quality management and lab systems (COMET or similar); LabVantage eLIMS is a plus.
• Strong analytical, root-cause, and organizational skills with attention to detail and the ability to manage multiple priorities.
• Clear written and verbal English; Dutch is a plus; collaborative communicator who works well independently and in cross-functional teams.

Preferred Skills:

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy

Hybrid work