Quality Assurance Specialist

Job Title
:
Quality Assurance Specialist

• Location:
  
  Framingham, MA

Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.

Core

Responsibilities include:

• Provide Gemba Support

• Perform batch record review

• Perform review of column packing and qualification records

• Function as SME on input related to quality decisions

• Approve Non-conforming material discards

• Perform log book review

• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps

• Issue action notices and conduct affiliated provisional release

• Conduct log book audits against compliance requirements

• Review Cleaning Verification (CV) related documentation against specification

• Perform media / buffer and intermediate release

• Prepare Bioreactor summary

• Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections

• Execute containment activities

• Provide off-hour support for batch record and log book issuance

• Partner with manufacturing and support operations to ensure a culture of continuous compliance

• May provide training to new employees

• Revise procedures / SOPs

• Initiate and Investigate and QA review deviations

• Review NRSR (Non-Routine Sample Requests)

• Other activities as assigned

* Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Being honest and treating people with respect and courtesy.

• Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.

• Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and /or other CGMP…