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Sanofi Group 2019 Biologics Co-Op: Quality Assurance (QA) Operations in Allston, Massachusetts

Title: 2019 Biologics Co-Op: Quality Assurance (QA) Operations

Location: Allston, MA

Duration: July 2019 – December 2019

Note: Candidates must be available 40 hours per week, Monday-Friday

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Discover your future…

Sanofi’s university opportunities offer exposure to a fast-paced and collaborative environment. Students work side-by-side with biopharmaceutical professionals, providing an opportunity to make an impact in the lives of patients around the globe. This Co-Op may lead to a full-time opportunity upon graduation based on successful performance reviews and final interview process. One of the goals of this program is to feed a leadership pipeline of top talent for our Sanofi Biologics full-time opportunities. Sanofi Biologics early career hiring launches your career to the next level through a targeted approach.

Department Description:

Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi Genzyme. The main role is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is also responsible for providing support and guidance 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.

Responsibilities:

Demonstrate 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. Acting with integrity and treating people with respect and courtesy. Constantly striving to make Sanofi Genzyme a great place to work, and a company respected for the quality of its people and products. This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's. The responsibilities include but are not limited to: Operations Responsibilities: Perform record issuance and record review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA. Conduct review of manufacturing processes to ensure compliance. Conduct review of testing results in support of release of intermediates. Provide compliance guidance to other support teams. Lot/ Intermediate Disposition Responsibilities: Participate in bulk shipment oversight activities. Participate in Quality release activities of manufactured intermediates. Deviation/CAPA Management Responsibilities: Work closely with manufacturing and support groups to resolve all deviations within agreed timelines. Perform deviation investigation activities, including; GEMBA, containment, classification and initial impact assessment. Support root cause analysis for deviations related to equipment, utilities, facilities, metrology and validation. Assist in deviation/nonconformance identification and resolution. May act as team member to investigate deviations to determine appropriate root cause and CAPAs.

Quality Engineering Responsibilities: Work with functional groups across the site to review and approve quality and technical documentation including: deviations, CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation. Review unscheduled maintenance and facility alarms, specifically the return to service testing and assessing potential impact to product. May provide support for visual inspections of vessel surfaces, when required. Assist in the development of robust maintenance procedures. Additional Responsibilities: Participant in internal audits. Participant in Lean initiatives to improve Quality processes. Participant in QA audit readiness program as well as assist and participant in external audits and regulatory inspections. Participate in the QA consistency meetings to drive continuous improvement efforts. Support the QA on the floor initiatives which includes; attending daily MDI meetings and assisting customers with resolution of issues in real time. May provide training to new employees. Effectively interact on a cross functional basis providing QA guidance at the area level and escalate any issues to Management in a timely fashion. Ensure that department goals are achieved and on time Quality product is realized through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.). Comply with the requirements of Sanofi Genzyme's health and safety program.

Basic Qualifications:

  • Pursuing a bachelor’s degree in Life Sciences with plans to graduate by 2020

  • 3.0/4.0 GPA is a minimum requirement

  • Must have permanent US work authorization

Preferred Qualifications:

  • Strong attention to detail and analytical skills

  • Demonstrated leadership skills

  • Excellent communication and interpersonal skills

  • Desire to work within a team environment

  • Strong interest in working with computers

  • Knowledge of Microsoft Office products, including Excel, Power Point and Word

Application Instructions:

  • Please apply online

  • Please complete the mandatory application survey, select "Biologics Co-Op Program - MA": https://sanofi.recsolu.com/external/form/wqUR9_B4uCCCMH1yOLg4hg

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Sanofi US Services, 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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