QC Analyst II/III (Sterility Microbiology) - Operations

Job Description

Do you have expertise in, and passion for, Quality Control? Would you like to apply your expertise to impact the Quality organization in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the global leading pharmaceutical companies.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 experts in our field, and it is only a short drive from Washington, DC. It is filled with cutting edge technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and inspired at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

As a QC Microbiology Analyst in the Quality Control group at Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patient's lives.

**This position is posted as a QC Analyst II or III based on experience**

Main Responsibilities:

• Serve as lead for investigations and Environmental Monitoring.
• Responsible for sampling and conducting routine and non-routine analysis of environmental samples, in process and finished products.
• Sampling of WFI and purified water systems, clean steam, and compressed gases. Testing of water and product samples including conductivity, bioburden, endotoxin, TOC and microbial ID’s, growth promotion, nano filtration, A280, water analysis
• Complete appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.
• Review data acquired for compliance to specifications and reports abnormalities. Analyzes data for trending or archiving and enters data into system.
• Prepares validation protocols, executes experiments, and prepares validation reports.
• Responsible for writing new standard operating procedures or revising existing documentation.
• Prepares documentation for presentation to Regulatory Agencies.
• Review of testing and documentation where required.
• Calibrates, troubleshoot and maintains laboratory equipment as necessary.

Minimum Requirements:

• BS degree in a scientific field
• Minimum of 1+ years of relevant QC experience (QC Analyst II)
• Minimum of 3+ years of QC experience (QC Analyst III)
• Previous experience leading investigations required.
• Experience working in a sterile/aseptic environment strongly preferred

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them