Quality Control Microbiologist

Role: QC MicrobiologistLocation: Fully on site in Dundalk, IrelandContract: Until June 2026 (with possibility of extension)- Full-time, 39 hours weeklyCompany: A Global Pharmaceutical Company Role Overview: Reporting to the Microbiology Lead, this role provides real-time QC oversight for Drug Substance/Drug Product manufacturing. It is a key position within Quality, directly supporting daily manufacturing activities to ensure compliance with cGMP and corporate/local SOPs.Key responsibilitiesProvide QC support for technology transfer and commercial manufacturing operations.Review SOPs, risk assessments, change controls, and related documentation for DS/DP operations.Lead/participate in microbiology projects: microbial method validation and testing, environmental monitoring, organism identification, facility qualification, cleaning validation, and process validation.Perform microbial testing; support atypical/OOS investigations; drive/track change controls and CAPAs.Monitor and trend method performance with supervisors and cross-functional partners.Author technical documents: methods, protocols, validation/qualification plans and reports, SOPs.Offer technical guidance and assess/introduce new microbiology technologies.Support the Microbiology Lead in developing microbial control strategies, quality enhancements, and operational efficiency improvements.Communicate effectively and take a lead role in project management interactions with internal and external stakeholders (e.g., Quality Assurance, Regulatory Affairs, Analytical Development, clients).Serve as a primary point of contact for project coordination, including emails and client meetings.Prepare for and participate in regulatory inspections (e.g., FDA, EMA) and client/internal cGMP audits.Perform all tasks in compliance with applicable regulations, international standards, and company policies and SOPs.Other duties as assigned.EducationBSc in Microbiology or a related discipline.1–3 years of relevant industry experience.Work experienceExperience in a highly regulated environment.Ability to interpret technical documentation.Working knowledge of cGxP requirements and regulations.Practical problem-solving skills, including formal root-cause tools (e.g., Ishikawa, FMEA).Professional knowledgeMicrobiological testing and peer review.GMP compliance and inspection readiness.