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QC – Microbiology Specialist
3 weeks ago
ref. 01199
QC – Microbiology Specialist
Maternity leave cover opportunity for a Microbiology Senior Technical Specialist with our client, a Biopharma leading company based in County Meath.
You'll be responsible for orchestrating, planning, and managing the daily functions of the laboratory alongside coordinating Microbiology validation tasks. Your role includes overseeing technical operations, supervising testing and review processes, and maintaining communication with laboratory clients to fulfill their needs. Additionally, you'll offer technical guidance, troubleshoot issues, provide training, and offer support to laboratory staff to ensure our company's standards for compliance, safety, and consistent customer service are met.
Responsibilities
• Collaborate within a self-directed work team to prioritize testing and task assignments, spanning daily, weekly, monthly, and quarterly objectives. Execute tasks with exceptional precision and accuracy, while also fostering a culture of excellence among team members.
• Liaise with external groups such as Manufacturing, Tech Ops, CQV, Plant Engineering and QA to ensure laboratory support is available as required and testing timelines are met.
• Guarantee adherence to lab testing schedules, applying Lean Lab methodology.
• Ensures projects are supported and completed as per project timelines. Anticipated delays should be escalated, with proposed solutions for resolution.
• Author/provide leadership in the Laboratory/Contamination investigations using own initiative and with minimum supervision.
• Ensures testing/data review are supported and that results are available within lead times to laboratory customers. Anticipated delays should be escalated, with proposed solutions for resolution.
• Coach and mentor the Laboratory Team, while driving Continuous Improvement in the lab including implementation of lean projects
• Work as directed by according to Company safety policies, cGMP and cGLP.
• Ensure the Lab Tier/handovers are facilitated, and attendance expectations are met.
• Support audit/inspection requirements to ensure department compliance/readiness.
• Be involved in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
Requirements
• Bachelor's Degree or higher is a preference, ideally in Microbiology or a related discipline.
• Strong knowledge in microbiology related lab test method methods e.g. Environmental Monitoring, Microbial Identifications, Bioburden testing, Endotoxin testing, Biological Indicator Testing, Absence of Contamination Testing (BacT), Growth Promotion/Sterility Testing.
• 8 years+' experience in the Microbiology Pharmaceutical industry or a similar operating environment.
• New Product Introduction and Microbiology Method Validation experience.
• Experience in Investigation and demonstrated project work.
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