Sanofi Group Quality Control Analyst I in Lynnwood, Washington

The Quality Control Biological and Facilities Testing group supports manufacturing activities at Genzyme Northpointe Facility by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. The group supports the environmental and critical utility monitoring program of the production facility and support areas. The QC BFT group performs key microbiological assays supporting BDS, cell bank and drug product release. The QC BFT group routinely interacts with production, engineering, validation and other QC groups.

This individual will report to the QC Supervisor and will contribute to general operations and testing of the QC BFT lab. QC Analyst I works independently under general supervision. Primary responsibilities include, but are not limited to the following: collect and process samples in a timely manner, microbiological routine testing of environmental, critical utility, in-process, validation samples, BDS and drug products in accordance with SOPs and cGMP regulations; review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.

Major Responsibilities and testing may include but are not limited to:

• Perform critical utility monitoring, including water, steam, compressed air

• Perform Environmental Monitoring, including surface, particulate and viable air monitoring.

• Perform Biological Indicator Testing

• Perform Endotoxin Testing

• Perform Bioburden Testing

• Receipt and disposal of samples in the QC lab

• Autoclave QC micro equipment

• Troubleshoot assay and instrument problems with Laboratory Supervisor

• Enter data in LIMS and Apollo database as necessary

• General maintenance of Lab equipment

• Participate in writing and revising SOPs, protocols

• Assist in the development and optimization of testing methods

• Maintain log books

• Ensure labs are clean and safe (in compliance with CGMP) and properly stocked

• Make detailed observations in support of Alert, Action and OOS result investigations

• Participate in the qualification of equipment, methods, and processes

• Participate and perform special studies & projects assigned to microbiology

• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.

• Perform other additional job related duties as required

BASIC QUALIFICATIONS:

• Bachelor’s Degree in Life Sciences discipline

PREFERRED QUALIFICATIONS:

No prior industry experience required

• Microsoft Office

• 1 Year Experience in a CGMP lab environment

• Proficient in Outlook and MS Word and Excel and lab based data management systems

• Experience with environmental monitoring including water testing

SPECIAL WORKING CONDITIONS:

• Must be able to lift 40 lbs

• Must be able to gown and gain entry to manufacturing areas

• Must be available to work some Sundays and occasional holidays

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.