Analyst, Quality Control Environmental Monitoring, Cell Therapy

AstraZeneca - Gaithersburg, MD

Full-time - Entry Level

Gaithersburg, MD

Chemical Manufacturing

About the position

As a QC Environmental Monitoring Analyst at AstraZeneca, you will play a crucial role in ensuring the quality of our cell therapy products through rigorous microbial environmental monitoring and testing. This position is integral to our Operations team, where you will be responsible for performing routine quality control laboratory tasks, including the maintenance of laboratory equipment and writing or revising Standard Operating Procedures (SOPs). Your expertise in cell therapy cleanrooms will be essential as you apply scientific methods and techniques to solve complex problems and ensure compliance with Good Manufacturing Practices (GMP). In this role, you will be expected to execute tests with a high degree of accuracy and reliability, contributing to our commitment to quality and excellence. You will work collaboratively within a high-performing team, leveraging your strong interpersonal and communication skills to navigate a cross-functional matrix environment. Your ability to critically analyze data and reports will be vital in maintaining the integrity of our testing processes and ensuring that our products meet the highest standards of quality. AstraZeneca is dedicated to innovation and continuous improvement, and as part of our team, you will be at the forefront of implementing new technologies and methodologies to enhance our operations. You will have the opportunity to contribute to our mission of delivering life-changing medicines to patients while fostering an inclusive and equitable workplace where diverse perspectives are valued and encouraged.

Responsibilities

• Perform microbial environmental monitoring and testing in compliance with GMP standards.
• Maintain laboratory equipment and ensure the cleanliness and organization of the QC lab.
• Write and revise Standard Operating Procedures (SOPs) as needed.
• Analyze and report on environmental monitoring data and trends.
• Collaborate with cross-functional teams to address quality control issues and implement solutions.
• Apply scientific methods and techniques to solve complex problems in the QC environment.

Requirements

• Bachelor's degree in Biological Sciences, biology, microbiology, or a related discipline.
• Minimum of 2 years of experience in a pharmaceutical or biotech QC environment, focusing on microbial testing.
• Prior experience in a Quality Control or GMP testing laboratory with knowledge of cGMP and regulatory requirements.
• Strong ability to work collaboratively as part of a high-performing team.
• Excellent interpersonal, verbal, and written communication skills.

Nice-to-haves

• Experience with cell-based products, particularly CAR T-cells.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance coverage.
• 401(k) retirement savings plan with company matching.
• Paid time off and holidays.
• Opportunities for professional development and continued education.
• Flexible working arrangements to support work-life balance.