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