**Rotating day and night shifts including holidays and weekends**
**Flexible to work overtime as per business needs**
** Join Sanofi and be a part of the team working until the final whistleto develop a COVID-19 vaccine**
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.
POSITION OVERVIEW/KEY RESPONSIBILITIES:
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.
Practices and promotes safe work habits and adheres 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 and subtle variances that deviate from normal operation; participate as needed in investigations.
Maintains cleanliness and orderliness of process area.
Maintains production area with supplies.
Prepares and operates large scale manufacturing equipment and systems
Performs clean in place operations to prepare equipment for manufacturing operations.
Performs batch record review, procedure revisions, and work order generation.
May be responsible for training less experienced or new operators.
May be designated as a lead operator on manufacturing operations.
Utilizes manufacturing knowledge to improve process operations and affect positive change.
Demonstrates ability to troubleshoot basic mechanical operations.
Effectively utilizes Microsoft office applications.
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.
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 3-5 years of experience in cGXP manufacturing environment, or Bachelor’s Degree with 1-3 years of experience
Familiarity with Manufacturing Control Systems (i.e. DeltaV).
Extended experience in large-scale manufacturing operations.
Experience in a GXP environment.
Experience facilitating and delivering training.
Experience creating controlled documents.
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 scheduled 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.