Sanofi Group Quality Control Analyst II, Allston, MA in Allston, Massachusetts

This individual will report to the QC shift Supervisor in the Allston Quality Control laboratory and will contribute to general operations and testing of the QC Microbiology laboratory. This role is 2nd shift, Sunday - Thursday 1:00 PM - 11:30 PM. QC Analyst II works independently with minimal supervision. Primary responsibilities include, but are not limited to the following: collect and process samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and final products in accordance with SOPs and CGMP regulations, review laboratory assay documentation for accuracy and timeliness, 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 Water, Steam and Critical Utility collection as well as associated testing

• Perform Environmental Monitoring

• Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric)

• Perform Bioburden Testing of In-process products, buffers, and water

• Biological Indicator Testing

• Perform Growth Promotion Testing

• Perform Plate Reading

• Receipt of manufacturing samples into the QC lab as well as sample retain disposal

• Autoclave QC micro equipment

• Troubleshoot assay and instrument problems with Laboratory Supervisor

• Enter and review data in LIMS

• Conduct data analysis based on sample specification

• Perform safety and operational lab audit

• General maintenance of Lab equipment

• Participate in writing and revising SOPs

• Assist in the development and optimization of testing methods

• Maintain log books related to inventory and equipment

• 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

• Performs other additional job related duties as required

• Performing routine QC testing of in-process and final products in a CGMP lab for

release.

• Container closure testing, particulate testing, HACH, and plate

streaking.

• Provide training and technical leadership to less experienced staff.

• Participate in authoring complex and explicit documentation (Protocols and technical

reports).

• Involvement in equipment qualification (IQ, OQ, and PQs) and method validation.

Basic Qualifications:

Bachelor’s Degree in Life Sciences discipline and 2 years experience in CGMP lab

environment

Or

• Master’s Degree in Life Sciences discipline and 1 year experience in CGMP lab

Environment

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

systems

Experience with environmental monitoring including water testing

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life