Quality Control Analyst I

Sanofi - Ridgefield, NJ

Full-time - Entry Level

Ridgefield, NJ

10,001+ employees

Chemical Manufacturing

About the position

The Micro QC Analyst I is a key role within the Quality Assurance Department, focusing on microbiological testing and environmental monitoring in aseptic production areas. This position is essential for ensuring compliance with cGMP standards and maintaining the integrity of the microbiology laboratory. The analyst will engage in various tasks including data entry, SOP creation and review, and collaboration with project teams to support site operations.

Responsibilities

• Conduct various microbial testing and environmental monitoring for aseptic production areas.
• 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 environmental monitoring sampling results and other lab data.
• Collaborate with project teams and cross-functional groups related to site operations.
• 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 working with bacteria, yeast, and mold.
• Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing.
• Excellent technical writing skills.
• Ability to collaborate effectively with personnel across departments.
• Strong problem-solving skills and communication abilities.
• 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 OOS investigations writing.
• Familiarity with compliance to safety and environmental regulations.

Benefits

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