QC Sample and Raw Material Coordinator

QC Sample and Raw Material Coordinator

The individual in the role will be in charge of sample management and shipping of drug substances, drug products, and raw material samples throughout the Contract Manufacturing sites, Sanofi Network sites, and Contract testing sites.

The incumbent will also serve as the single point of contact for raw material testing, including results gathering, and serve as liaison between the release groups for timely provision of test data.

The incumbent will also support the management in handling all administrative tasks related to sample test coordination between multiple sites.

KEY RESPONSIBILITIES :

Coordinating, packaging, and shipping product test samples for contract testing at External laboratories, Sanofi Network sites, and other third parties.

Track all Raw material testing tasks and serve as the sampler for Raw materials for QC testing and other requirements at both Meriden, CT and Pearl River, NY locations.

Support testing as required.

Handle all administrative tasks related to sample / results management in a timely and compliant manner.

Serve as the single point of contact for all raw material testing and results coordination.

Alert management on testing issues including Out of Specifications, Deviations, and other laboratory events at external sites.

Serve as the QC liaison for Raw Material related issues with the product release group.

Serve as the material coordinator for the QC lab, including the tracking of critical reagents and sourcing / ordering of day to supplies and chemicals / reagents.

Aggregate data for release binders for Drug Substances, Drug Products, and other associated test documents for final review by QC management.

Tabulate and maintain QC data including stability data, routine release data, and serve as the data entry person for all QC and externally generated data.

Support management in data retrieval for reports and protocols.

Assist in the support and management of laboratory equipment including daily monitoring and maintenance tasks.

Promote a safe, positive, and compliance-driven work environment

Other responsibilities as assigned by the laboratory management.

Ability to travel between network sites at Meriden, CT and Pearl River, NY is required.

BASIC QUALIFICATIONS :

BS degree in Science, Engineering, or related field.

3+ Years of laboratory / manufacturing experience in a pharmaceutical or related industrial environment.

SKILLS :

Familiarity with routine laboratory operations including handling test materials, chemicals, reagents, and samples.

Prior experience in logistics is highly desirable.

Excellent organizational skills with aptitude for multi-tasking.

Strong and effective communication skills required.

Experience in Electronic systems such as LIMS is desired.

A good command of Microsoft Excel as an organizational tool is highly desired.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.

All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.

LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.