QC Senior Analyst, Microbiology

Are you ready to make a significant impact in the world of microbiology? As a QC Senior Microbiology Analyst, you'll play a crucial role in supporting the Bulk Drug Facility in Dublin. Your expertise will be vital in conducting microbiological testing, including Environmental Monitoring, Water sampling, TOC, Bioburden, and Endotoxin. Join us in ensuring the highest standards of quality and compliance!

Accountabilities:
- Conduct environmental and facilities monitoring sampling and testing.
- Maintain high cGMP and GLP standards while adhering to schedules and targets to meet regulatory and business requirements.
- Validate and qualify microbiology test methods and systems such as the Endotoxin test system and Identification system.
- Represent the Microbiology department in audits, both internal and external.
- Close out actions and recommendations from audits.
- Evaluate compliance issues and trends, providing training where necessary.
- Stay updated with new technologies, procedures, and methods in the Microbiology Laboratory.
- Perform technical reviews of laboratory data, validation protocols, and reports.
- Provide technical support to manufacturing and projects through participation, investigation, validation, and testing activities.
- Ensure all instruments/equipment are maintained in a calibrated and operational state.
- Maintain high standards of housekeeping and safety in the laboratory.
- Complete project work and implement initiatives to improve laboratory efficiency.
- Keep management informed of laboratory issues.
- Schedule testing, review, and authorize microbial data.
- Investigate out-of-specification results using Structured Problem Solving and Root Cause Analysis tools.
- Train laboratory personnel and contribute to training/re-training programs.

Essential Skills/Experience:
- Minimum of 3 years experience in cGMP Quality environment.
- Experience in testing sterile/non-sterile pharmaceutical/biopharmaceutical products.
- Good knowledge of current regulatory requirements for Microbiology/Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Degree in Microbiology or related science.
- Ability to lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience:
- Excellent problem-solving and root cause analysis skills.
- Innovative approach to developing efficient and compliant processes and procedures.
- Strong organizational skills.
- Ability to plan/schedule work for self and subordinates and delegate tasks appropriately.
- Excellent written and oral communication skills.
- Ability to develop collaborative relationships with other functions and sites to achieve goals.

At AstraZeneca, we are driven by a passion for innovation and a commitment to making a difference. Our unique culture combines the agility of a biotech with the resources of a global biopharma. We are dedicated to transforming lives through groundbreaking research and development. Here, you will find an environment that fosters growth, collaboration, and the pursuit of excellence. Join us on this journey where your contributions will have a profound impact on patients worldwide.

Ready to take the next step in your career? Apply now to become part of our dynamic team!

Date Posted

20-Nov-2025

Closing Date

26-Nov-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.