**Rotating day and night shifts including holidays and weekends**
**Flexible to work overtime as per business needs**
Who You Are
You are a flexible learner who can take on multiple aspects of Quality Compliance. You have the ability to work across the organization to influence Quality Culture and ensure adherence to procedures and GMP processes. You excel in a fast-paced and dynamic environment requiring problem solving and attention to detail. You enjoy working in a collaborative and supportive team setting.
Who We Are
The Quality Assurance (QA) department is responsible for quality oversight of operations at Sanofi Framingham Biologics facilities. QA main responsibility is to ensure adherence to CGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. QA 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.
Where We Are
Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service. Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations. Sanofi recently completed a multi-year capital expansion with several buildings constructed using “green” technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.
The Manufacturing Department performs multi-stage large scale solution & equipment preparation, cell culture, media preparation, chromatography, tangential flow filtration operations, final formulation operations, and/or preparation of bulk product for shipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.
- Practices safe work habits and adhere to Sanofi's safety procedures and guidelines.
- Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
- Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
- Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations.
- Maintains cleanliness and orderliness of process area.
- Stocks production area with supplies.
- May perform support function for more senior operators.
- Prepares and operates large scale manufacturing systems
- Performs clean in place operations to prepare equipment for manufacturing operations.
- Assists in the creation and revision of manufacturing documentation by providing input to technical composition of document.
- Identifies and assists with troubleshooting routine issues and defects.
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 of 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.
- High school diploma/GED with 6 months experience in a cGMP manufacturing environment -- OR --Associates or Bachelor degree with no prior experience.
- Biotech Certificate
- Effectively uses process automation systems to operate production processes (i.e. DeltaV).
- Experience in reviewing and creating controlled documents.
- Familiarity with Deviation Management Systems (i.e. Phenix).
SPECIAL WORKING CONDITIONS:
- Ability to lift up to 50 lbs.
- Ability to stand on average 10 hours per shift.
- Ability to gown and gain entry to manufacturing areas
- Ability to work a twelve hour rotating shift and every other weekend, including some holidays.
- Ability to work in a cold room environment (2-10 degrees C).
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.
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.