Offers “Sanofi”

Expires soon Sanofi

Quality Control Analyst II, Waltham, MA

  • Waltham (Lincolnshire)
  • Design / Civil engineering / Industrial engineering

Job description

THIS IS AN 8 HOUR MON-FRI SHIFT AT THE WALTHAM FACILITY

QC Analyst II

Department Description:

Quality Control Molecular Biology supports manufacturing activities at Sanofi's Framingham, Allston, and Northborough Campus by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of viral control in the manufacturing and raw material process. It assesses the aseptic quality of product and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

Position Overview/Key Responsibilities

Position Summary

Contribute to general operations and testing of the QC Molecular Biology laboratory. Work independently under general supervision to conduct microbiological routine testing of environmental, critical utility, raw materials, in-process, validation samples and final products in accordance with SOPs and cGMP regulations. Review laboratory assay documentation for accuracy and timelines, evaluate preliminary results; aid in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties

Core Responsibilities

·  Collect and receive samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
·  Troubleshoot assay and instrument problems with Laboratory Supervisor
·  Enter and review data in LIMS
·  Perform safety and operational lab audit
·  General maintenance of lab equipment
·  Participate in writing and revising SOPs, protocols
·  Maintain log books related to inventory and equipment
·  Ensure labs are clean and safe (in compliance with cGMP) and properly stocked
·  Make detailed observations in support of OOS result investigations
·  Participate in the qualification of equipment, methods and processes
·  Perform viral testing using PCR methods
·  Provide training and technical leadership to less experienced staff
·  Participate in authoring complex ad explicit documentation
·  Perform routine Quality Control testing of in-process and final products in a cGMP lab for release
·  Practice safe work habits and adhere to Sanofi's safety procedures and guidelines
·  Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

Leadership Qualifications:

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 a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs

Basic Qualifications:

·  Bachelor's degree and 2+ years in Life Sciences discipline
·  Masters degree and and 1 year in a Life Science discipline

Preferred Qualifications:

·  Experience with PCR methodology preferably on Applied Biosystems Real time Platform
·  Knowledge of cGMP and previous experience in a cGMP Lab
·  Knowledge of lab based data management systems

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.

#GD-GZ

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.

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