Quality Technician - Quality Control

**This position will be filled as an 8:00 AM to 4:30 PM Sunday - Thursday position with occasional off shift and holiday work required when necessary.

The Quality Technician - Quality Control candidate filling this position will performs testing in the Quality Control Bioassay laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP and Sanofi policies and procedures. This position requires the individual to perform routine testing as scheduled to support production, method validation as well as the stability program and completing required documentation. They will also be required to perform cleaning of work areas, equipment, and any other jobs as required, ensure all duties are completed on time, and complete required Safety and Compliance training and associated training modules as assigned. Knowledge and experience of immunology based testing is preferred (SRID and ELISA based assays).

KEY ACCOUNTABILITIES:

Testing:

Performs current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), Sanofi policies and procedures and safety procedures. Performs testing as per testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand and Stability program. Completes required paperwork and documentation as required. Ensures product integrity by testing products, pulling samples, placing work orders and visual inspection of samples. Prepares for and operates QC equipment including pre and post run setup and maintenance. Troubleshoots sample discrepancies. Performs peer proofing on assays.

Laboratory:
Maintains laboratories in a safe and compliant state. System related functions: SAP (Cycle counts, confirmations, inventories, etc.), Trackwise (MDOs & IPDNs), LIMs (inventories), etc. Performs cleaning of laboratories, equipment, and ancillary areas as required.

Training:
Attends/Contributes to scheduled team meetings, department meetings, and safety meetings. Document review. Safety and compliance training. Module/Assay training as assigned. Professional/Technical development training on/ off-site as assigned.

Compliance:
Understand and support implementation of Change controls, CAPAs, and deviation corrective actions. Notifies laboratory manager of any deviations or issues and initiates incident investigations as required. Support deviations.

All other duties as assigned

QUALIFICATIONS:
Education/experience

• 4-year science degree (Biology, Immunology and related disciplines)

• 1 - 3 years of relevant experience (immunology, biology).

• Good mathematical skills and computer literacy.

• Excellent organizational, verbal communication, and written communication skills.

• Ability to work efficiently with minimal error and high attention to detail.

• Experience directly working in a cGMP facility, including QC testing is preferred.

Vaccinations required:

• Annual Flu Vaccination

• Covid-19 Vaccination

• Other vaccinations required on a job function basis TBD.

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.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE

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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