Quality Control Analyst I

Sanofi - Ridgefield, CT

Full-time - Entry Level

Ridgefield, CT

Chemical Manufacturing

About the position

The Micro QC Analyst I position is dedicated to the Microbiology Laboratory and Environmental Monitoring (EM) Program within the Quality Assurance Department. This role involves various microbial testing, monitoring aseptic production areas, and ensuring compliance with cGMP standards. The analyst will also be responsible for data entry, SOP creation and review, and collaboration with project teams to enhance operational efficiency.

Responsibilities

• Conduct various microbial testing and EM monitoring for the Micro team.
• Order and stock laboratory supplies as needed.
• Create and review Standard Operating Procedures (SOPs).
• Write investigations for Out of Specification (OOS) results.
• Perform data entry for EM sampling results and other lab data.
• Collaborate with project teams and cross-functional groups.
• Assist fellow analysts in the Micro department.

Requirements

• BA/BS in Microbiology/Biology with at least 1 year of experience in a cGMP, pharmaceutical, or laboratory environment.
• Practical experience in general microbiology laboratory techniques, including working with bacteria, yeast, and mold.
• Working knowledge of cGMPs in pharmaceuticals, biologicals, aseptic, or medical device manufacturing.
• Excellent technical writing skills and problem-solving abilities.
• Strong communication skills and ability to work independently.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Nice-to-haves

• Experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, or endotoxin assays.
• Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D areas.
• Experience with SOP review, creation, and approval.
• Prior experience with data review, authoring SOPs, Change Controls, and report writing.

Benefits

• High-quality healthcare coverage.
• Prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Opportunities for career growth and development.