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Quality Control Senior Analyst-Framingham,MA

Company: Sanofi
Location: Framingham
Posted on: August 4, 2022

Job Description:

POSITION OVERVIEW:Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. Quality Control is also responsible for assisting in site wide studies and projects.This position is responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs and relevant procedures for method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.This Senior QC Analyst is responsible for performing routine to complex techniques associated with daily QC release and provides an investigative or technological orientation in implementing, executing and interpreting quality procedures and test methods.Responsibilities includePerform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.Perform maintenance on complex laboratory equipment.Review data for compliance to procedures and specifications.Calculate and evaluate results.Make detailed observations in support of Alert, Action and OOS result investigations.Participate in writing and revising SOPs.Assists in the qualification of new controls, standards, and reagentsEffectively demonstrate an understanding of and work in compliance with CGMPs.Practice safe work habits and adhere to Sanofi's safety procedures and guidelines.Actively participate in problem solving meetings with senior staff members and suggest process improvements.Independently work under supervision and direction.* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needsLEADERSHIP QUALIFICATIONSAn 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:Being a Subject Matter Expert (SME)/Trainer/Coach to other analysts within the laboratory.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.BASIC QUALIFICATIONSBachelor's Degree in Life Sciences discipline and 4 years experience in cGMP lab environment, orMaster's Degree in Life Sciences discipline and 2 year experience in cGMP lab environment.Scientific technical writing ability.Basic knowledge (i.e., 1-2 years experience) in the required method platform (e.g. Bioburden, TOC, Endotoxin, Water Chemistry, ELISA).Attention to detail, and able to maintain accurate records with excellent proofreading skillsAble to communicate effectively with othersAble to work effectively both independently and as a member of a teamProficient in Outlook and Microsoft Word and Excel and lab based data management systems.PREFERRED QUALIFICATIONSExperience in GMP lab environment.Experience with lab based data management systems.Experience in a quality control lab.SPECIAL WORKING CONDITIONSWork in a laboratory with minimal use of chemicals.Ability to lift 10 lbs.Shift: 1st shift, Wed-Sat 7-530All or part of the information contained in this document should be treated as the property of Sanofi or its affiliates. It cannot be published or divulged for whatever purpose to any third party, unless an appropriate non-disclosure agreement has been signed by the third party and prior approval is obtained from the Sanofi function owning this document.Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. 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-SG#LI-GZAt 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.

Keywords: Sanofi, Framingham , Quality Control Senior Analyst-Framingham,MA, Professions , Framingham, Massachusetts

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