QC Senior Analyst

Are you ready to make a difference in the world of biopharmaceuticals? As a QC Senior Analyst at our Athlone facility, you'll play a pivotal role in supporting the QC department with technical expertise in facility testing oversight, test method validation, and the integration of new technologies. You'll be the go-to expert on product testing and environmental monitoring, responsible for deviation and technical writing. Join us in our mission to bring innovative solutions to patients worldwide!

Accountabilities

- Ensure high cGMP and GLP standards are maintained, meeting regulatory and business requirements.
- Validate and qualify microbiology test methods and systems, including Endotoxin and Identification systems.
- Collaborate with the QC System Specialist to implement LIMS for the Microbiology Laboratory.
- Lead and participate in Quality Risk Assessments related to Microbiology.
- Maintain regulatory compliance through laboratory testing programs, training, SOPs, and validation.
- Represent the Microbiology department during internal and external audits.
- Close out actions/recommendations from audits.
- Evaluate compliance issues and trends, providing training as needed.
- Train laboratory personnel and contribute to training program development.
- Stay updated with new technologies, procedures, and methods in the Microbiology Laboratory.
- Investigate out-of-specification results using Root Cause Analysis tools and implement corrective actions.
- Perform technical reviews of laboratory data, validation protocols, and reports.
- Review and authorize microbial data.
- Represent the Microbiology laboratory at meetings.
- Provide technical support to Manufacturing and Projects through participation, investigation, validation, and testing activities.
- Keep management informed of laboratory issues.
- Ensure instruments/equipment are calibrated and operational.
- Organize and schedule laboratory operations in the absence of the Laboratory Supervisor.
- Troubleshoot laboratory issues using Root Cause analysis tools.
- Complete project work and initiatives to improve laboratory efficiency.
- Maintain high housekeeping standards in the Laboratory.

Essential Skills/Experience

- Degree in Microbiology or related science.
- Minimum of 5 years of experience in a cGMP Quality environment.
- Experience in testing sterile drug products and aseptic filling processes.
- Good knowledge of current regulatory requirements for Microbiology/Sterility Assurance.
- Subject Matter Expert in Method Validation, Endotoxin testing, and sterility testing.
- Experience in Quality Risk Management.
- Excellent knowledge of LIMS and experience in its implementation for Microbiology.

Desirable Skills/Experience

- High technical competency in Sterility Assurance, Aseptic filling, and microbiology methods.
- Ability to develop collaborative relationships with other functions and sites.
- 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 and delegate tasks effectively.
- Excellent written and oral communication skills.

At AstraZeneca, we are driven by a passion for innovation and a commitment to improving lives. Our unique culture combines the agility of a biotech with the resources of a global biopharma leader. Here, you'll find an environment that fosters growth, collaboration, and a deep connection to our mission. We are dedicated to making a meaningful impact on patients' lives by tackling some of the toughest challenges in healthcare. Join us in our journey to redefine what's possible in R&D and healthcare.

If you're ready to be part of a team that values innovation, collaboration, and making a difference, we want to hear from you!

Date Posted

18-Nov-2025

Closing Date

01-Dec-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.