Contamination Control, Senior Specialist

Are you ready to make a significant impact in the world of contamination control? As a Senior Specialist, you'll be at the forefront of implementing strategies that ensure the highest standards of microbial control across drug substance operations. Your expertise will guide Quality Risk Management activities and investigations, reinforcing aseptic practices and cleanroom behaviours. You'll deliver targeted training, monitor microbiological data, and drive continuous improvement. Collaborate with cross-functional teams to embed best practices and support audits and compliance. This role is office-based but requires substantial time on the manufacturing floor and in cleanrooms. Are you prepared to lead and innovate in contamination control?

Accountabilities

In this dynamic role, you'll execute contamination control programs with a focus on new product introductions and technology transfers. Own risk assessments and investigations, translating outputs into practical controls and CAPAs. Provide on-floor support to resolve issues in real-time with Operations. Coordinate and deliver training while maintaining associated documentation and competencies. Analyze environmental and utility microbiological data, escalate trends, and author GMP documentation. Implement improvements via change control, ensuring compliance and audit readiness. Perform tasks assigned by the Contamination Control Lead.

Essential Skills/Experience

- Bachelor’s degree in Science, Engineering or a related discipline.
- cGMP manufacturing experience in biotech, pharmaceutical, or biopharmaceutical environments.
- Proficient-level QRM experience (e.g., FMEA, HACCP, cause-and-effect), with a track record of converting outputs into effective controls and CAPAs.
- Strong GMP documentation skills for SOPs, protocols, and technical reports.
- Ability to analyze data and make objective, evidence-based recommendations.
- High proficiency in MS Office (Word, Excel, Outlook, Visio, PowerPoint).
- Self-motivated, detail-oriented, excellent organizational, communication, and interpersonal skills; capable of independent work and influencing across teams.

Desirable Skills/Experience

- 3–4 years’ experience in Microbiology, Quality Assurance, or Operations within regulated manufacturing.
- Experience with QRM tools, environmental monitoring systems, and data visualization.

At AstraZeneca, we are driven by a passion to innovate and create meaningful value in all we do. Our commitment to patients living with rare diseases inspires us to continuously strive for excellence. We foster a diverse and inclusive culture where ideas flourish and new thinking grows. With the entrepreneurial spirit of a leading biotech combined with the resources of a global pharma, we offer an environment where you can define your career path while making a difference in the lives of patients worldwide.

Ready to take the next step in your career? Join us at AstraZeneca and be part of a team that is changing lives every day!